81 FR 31944 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 98 (May 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 98 (May 20, 2016)
| Page Range | 31944-31945 | |
| FR Document | 2016-11856 |
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)] [Notices] [Pages 31944-31945] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11856] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-M-4948, FDA-2015-M-4949, FDA-2015-M-4950, FDA- 2016-M-0120, FDA-2016-M-0121, FDA-2016-M-0122, FDA-2016-M-0123, FDA- 2016-M-0803, FDA-2016-M-0804, FDA-2016-M-0805, FDA-2016-M-0806, FDA- 2016-M-0807, FDA-2016-M-0926, FDA-2016-M-0928] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket Nos. FDA-2015-M-4948, FDA-2015-M-4949, FDA-2015-M-4950, FDA-2016-M-0120, FDA-2016-M-0121, FDA-2016-M-0122, FDA-2016-M-0123, FDA-2016-M-0803, FDA-2016-M-0804, FDA-2016-M-0805, FDA-2016-M-0806, FDA-2016-M-0807, FDA-2016-M-0926, FDA-2016-M-0928 for ``Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire [[Page 31945]] Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524. SUPPLEMENTARY INFORMATION: I. Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from January 1, 2016, through March 31, 2016. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date. Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2016, Through March 31, 2016 ---------------------------------------------------------------------------------------------------------------- PMA No., Docket No. Applicant Trade name Approval date ---------------------------------------------------------------------------------------------------------------- H130006, FDA-2015-M-4950.............. Torax Medical, Inc....... FENIX Continence Restoration 12/18/2015 System. H140005, FDA-2015-M-4948.............. ARUP Laboratories........ PDGFRB FISH for Gleevec 12/18/2015 Eligibility in Myelodysplastic Syndrome/ Myeloproliferative Disease (MDS/MPD). H140006, FDA-2015-M-4949.............. ARUP Laboratories........ KIT D816V Mutation Detection 12/18/2015 by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM). P130007/S004, FDA-2016-M-0120......... Animas Corp.............. Animas Vibe System........... 12/24/2015 P900033/S042, FDA-2016-M-0121......... Integra LifeSciences Corp Integra Omnigraft Dermal 1/7/2016 Regeneration Matrix and Integra Dermal Regeneration Template. P080028, FDA-2016-M-0122.............. Storz Medical Ag......... Storz Medical Duolith SD1 1/8/2016 Shock Wave Therapy. P150011, FDA-2016-M-0123.............. LivaNova Canada Corp..... Perceval Sutureless Heart 1/8/2016 Valve. P150027, FDA-2016-M-0803.............. Dako North America, Inc.. PD-L1 IHC 28-8 pharmDx....... 1/23/2016 P150004, FDA-2016-M-0804.............. Spinal Modulation, Inc... Axium Neurostimulator System. 2/11/2016 P150022, FDA-2016-M-0805.............. Rex Medical, L.P......... Closer Vascular Sealing 2/12/2016 System. P120018, FDA-2016-M-0806.............. Sharps Terminator, LLC... Sharps Terminator............ 2/17/2016 P150005, FDA-2016-M-0807.............. Boston Scientific Corp... Blazer Open-Irrigated 2/24/2016 Ablation Catheter System. P130009/S037, FDA-2016-M-0926......... Edwards Lifesciences, LLC SAPIEN XT Transcatheter Heart 2/29/2016 Valve and Accessories. P020004/S123, FDA-2016-M-0928......... W.L. Gore & Associates, GORE EXCLUDER Iliac Branch 2/29/2016 Inc. Endoprosthesis. ---------------------------------------------------------------------------------------------------------------- II. Electronic Access Persons with access to the Internet may obtain the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm. Dated: May 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-11856 Filed 5-19-16; 8:45 am] BILLING CODE 4164-01-P
![31944 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
Advisory Committee and Oversight ACTION: Notice. 2016–M–0803, FDA–2016–M–0804,
Management Staff, Food and Drug FDA–2016–M–0805, FDA–2016–M–
Administration, 10903 New Hampshire SUMMARY: The Food and Drug 0806, FDA–2016–M–0807, FDA–2016–
Avenue, Silver Spring, MD 20993–0002, Administration (FDA) is publishing a M–0926, FDA–2016–M–0928 for
301–796–8220. list of premarket approval applications ‘‘Medical Devices; Availability of Safety
(PMAs) that have been approved. This and Effectiveness Summaries for
SUPPLEMENTARY INFORMATION: Under
list is intended to inform the public of Premarket Approval Applications.’’
section 10(d) of the Federal Advisory
the availability of safety and Received comments will be placed in
Committee Act (5 U.S.C. app.) and 21
effectiveness summaries of approved the docket and, except for those
CFR 14.60(d), FDA has filed with the
PMAs through the Internet and the submitted as ‘‘Confidential
Library of Congress the annual reports
Agency’s Division of Dockets Submissions,’’ publicly viewable at
for the following FDA advisory
Management. http://www.regulations.gov or at the
committees that held closed meetings
during the period October 1, 2014 ADDRESSES: You may submit comments Division of Dockets Management
through September 30, 2015: as follows: between 9 a.m. and 4 p.m., Monday
Center for Biologics Evaluation and Electronic Submissions through Friday.
Research
Submit electronic comments in the • Confidential Submissions—To
Blood Products Advisory Committee submit a comment with confidential
National Center for Toxicological following way:
• Federal eRulemaking Portal: http:// information that you do not wish to be
Research made publicly available, submit your
Science Board to the National Center www.regulations.gov. Follow the
instructions for submitting comments. comments only as a written/paper
for Toxicological Research submission. You should submit two
Center for Drug Evaluation and Comments submitted electronically,
including attachments, to http:// copies total. One copy will include the
Research information you claim to be confidential
Bone, Reproductive Health Drugs www.regulations.gov will be posted to
the docket unchanged. Because your with a heading or cover note that states
Advisory Committee
Joint Meetings of the Anesthetic and comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS
Analgesic Drugs Advisory solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The
Committee and the Drug Safety and comment does not include any Agency will review this copy, including
Risk Management Advisory confidential information that you or a the claimed confidential information, in
Committee third party may not wish to be posted, its consideration of comments. The
such as medical information, your or second copy, which will have the
Annual Reports are available for claimed confidential information
public inspections between 9 a.m. and anyone else’s Social Security number, or
confidential business information, such redacted/blacked out, will be available
4 p.m., Monday through Friday. for public viewing and posted on http://
1. The Library of Congress, Madison as a manufacturing process. Please note
that if you include your name, contact www.regulations.gov. Submit both
Bldg., Newspaper and Current copies to the Division of Dockets
Periodical Reading Room, 101 information, or other information that
identifies you in the body of your Management. If you do not wish your
Independence Ave. SE., Rm. 133, name and contact information to be
Washington, DC; and comments, that information will be
posted on http://www.regulations.gov. made publicly available, you can
2. The Dockets Management Branch provide this information on the cover
(HFA–305), Food and Drug • If you want to submit a comment
with confidential information that you sheet and not in the body of your
Administration, 5630 Fishers Lane, Rm. comments and you must identify this
1061, Rockville, MD 20852. do not wish to be made available to the
public, submit the comment as a information as ‘‘confidential.’’ Any
Dated: May 16, 2016. information marked as ‘‘confidential’’
written/paper submission and in the
Jill Hartzler Warner, manner detailed (see ‘‘Written/Paper will not be disclosed except in
Associate Commissioner for Special Medical Submissions’’ and ‘‘Instructions’’). accordance with 21 CFR 10.20 and other
Programs. applicable disclosure law. For more
[FR Doc. 2016–11853 Filed 5–19–16; 8:45 am] Written/Paper Submissions information about FDA’s posting of
BILLING CODE 4164–01–P Submit written/paper submissions as comments to public dockets, see 80 FR
follows: 56469, September 18, 2015, or access
• Mail/Hand delivery/Courier (for the information at: http://www.fda.gov/
DEPARTMENT OF HEALTH AND written/paper submissions): Division of regulatoryinformation/dockets/
HUMAN SERVICES Dockets Management (HFA–305), Food default.htm.
and Drug Administration, 5630 Fishers Docket: For access to the docket to
Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. read background documents or the
[Docket Nos. FDA–2015–M–4948, FDA– • For written/paper comments electronic and written/paper comments
2015–M–4949, FDA–2015–M–4950, FDA– submitted to the Division of Dockets received, go to http://
2016–M–0120, FDA–2016–M–0121, FDA– Management, FDA will post your www.regulations.gov and insert the
2016–M–0122, FDA–2016–M–0123, FDA– comment, as well as any attachments, docket number, found in brackets in the
2016–M–0803, FDA–2016–M–0804, FDA– except for information submitted,
2016–M–0805, FDA–2016–M–0806, FDA–
heading of this document, into the
marked and identified, as confidential, ‘‘Search’’ box and follow the prompts
2016–M–0807, FDA–2016–M–0926, FDA– if submitted as detailed in
mstockstill on DSK3G9T082PROD with NOTICES
2016–M–0928] and/or go to the Division of Dockets
‘‘Instructions.’’ Management, 5630 Fishers Lane, Rm.
Instructions: All submissions received
Medical Devices; Availability of Safety 1061, Rockville, MD 20852.
must include the Docket Nos. FDA–
and Effectiveness Summaries for
2015–M–4948, FDA–2015–M–4949, FOR FURTHER INFORMATION CONTACT:
Premarket Approval Applications
FDA–2015–M–4950, FDA–2016–M– Joshua Nipper, Center for Devices and
AGENCY: Food and Drug Administration, 0120, FDA–2016–M–0121, FDA–2016– Radiological Health, Food and Drug
HHS. M–0122, FDA–2016–M–0123, FDA– Administration, 10903 New Hampshire
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![Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 31945
Ave., Bldg. 66, Rm. 1650, Silver Spring, Act. The 30-day period for requesting The regulations provide that FDA
MD 20993–0002, 301–796–6524. reconsideration of an FDA action under publish a quarterly list of available
SUPPLEMENTARY INFORMATION: § 10.33(b) (21 CFR 10.33(b)) for notices safety and effectiveness summaries of
announcing approval of a PMA begins PMA approvals and denials that were
I. Background on the day the notice is placed on the announced during that quarter. The
In accordance with sections 515(d)(4) Internet. Section 10.33(b) provides that following is a list of approved PMAs for
and (e)(2) of the Federal Food, Drug, and FDA may, for good cause, extend this which summaries of safety and
Cosmetic Act (the FD&C Act) (21 U.S.C. 30-day period. Reconsideration of a effectiveness were placed on the
360e(d)(4) and (e)(2)), notification of an denial or withdrawal of approval of a Internet from January 1, 2016, through
order approving, denying, or PMA may be sought only by the March 31, 2016. There were no denial
withdrawing approval of a PMA will applicant; in these cases, the 30-day actions during this period. The list
continue to include a notice of period will begin when the applicant is provides the manufacturer’s name, the
opportunity to request review of the notified by FDA in writing of its product’s generic name or the trade
order under section 515(g) of the FD&C decision. name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2016, THROUGH MARCH 31, 2016
PMA No., Applicant Trade name Approval date
Docket No.
H130006, FDA–2015–M–4950 Torax Medical, Inc .................. FENIX Continence Restoration System ................................... 12/18/2015
H140005, FDA–2015–M–4948 ARUP Laboratories ................. PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syn- 12/18/2015
drome/Myeloproliferative Disease (MDS/MPD).
H140006, FDA–2015–M–4949 ARUP Laboratories ................. KIT D816V Mutation Detection by PCR for Gleevec Eligibility 12/18/2015
in Aggressive Systemic Mastocytosis (ASM).
P130007/S004, FDA–2016–M– Animas Corp ........................... Animas Vibe System ................................................................ 12/24/2015
0120.
P900033/S042, FDA–2016–M– Integra LifeSciences Corp ...... Integra Omnigraft Dermal Regeneration Matrix and Integra 1/7/2016
0121. Dermal Regeneration Template.
P080028, FDA–2016–M–0122 Storz Medical Ag .................... Storz Medical Duolith SD1 Shock Wave Therapy ................... 1/8/2016
P150011, FDA–2016–M–0123 LivaNova Canada Corp .......... Perceval Sutureless Heart Valve ............................................. 1/8/2016
P150027, FDA–2016–M–0803 Dako North America, Inc ........ PD–L1 IHC 28–8 pharmDx ...................................................... 1/23/2016
P150004, FDA–2016–M–0804 Spinal Modulation, Inc ............ Axium Neurostimulator System ................................................ 2/11/2016
P150022, FDA–2016–M–0805 Rex Medical, L.P .................... Closer Vascular Sealing System ............................................. 2/12/2016
P120018, FDA–2016–M–0806 Sharps Terminator, LLC ......... Sharps Terminator ................................................................... 2/17/2016
P150005, FDA–2016–M–0807 Boston Scientific Corp ............ Blazer Open-Irrigated Ablation Catheter System .................... 2/24/2016
P130009/S037, FDA–2016–M– Edwards Lifesciences, LLC .... SAPIEN XT Transcatheter Heart Valve and Accessories ....... 2/29/2016
0926.
P020004/S123, FDA–2016–M– W.L. Gore & Associates, Inc .. GORE EXCLUDER Iliac Branch Endoprosthesis .................... 2/29/2016
0928.
II. Electronic Access ACTION: Notice of availability. ADDRESSES: You may submit comments
Persons with access to the Internet as follows:
may obtain the documents at http:// SUMMARY: The Food and Drug Electronic Submissions
www.fda.gov/MedicalDevices/ Administration (FDA or Agency) is
ProductsandMedicalProcedures/ announcing the availability of a draft Submit electronic comments in the
DeviceApprovalsandClearances/ guidance for industry entitled ‘‘Chronic following way:
PMAApprovals/default.htm. Obstructive Pulmonary Disease: • Federal eRulemaking Portal: http://
Dated: May 16, 2016. Developing Drugs for Treatment.’’ This www.regulations.gov. Follow the
Leslie Kux, guidance is intended to assist sponsors instructions for submitting comments.
Associate Commissioner for Policy. in designing a clinical development Comments submitted electronically,
program for new drug products for the including attachments, to http://
[FR Doc. 2016–11856 Filed 5–19–16; 8:45 am]
treatment of chronic obstructive www.regulations.gov will be posted to
BILLING CODE 4164–01–P
pulmonary disease (COPD). This the docket unchanged. Because your
guidance revises the draft guidance of comment will be made public, you are
DEPARTMENT OF HEALTH AND the same name, issued November 9, solely responsible for ensuring that your
HUMAN SERVICES 2007, by adding information regarding comment does not include any
the St. George’s Respiratory confidential information that you or a
Food and Drug Administration Questionnaire (SGRQ). third party may not wish to be posted,
such as medical information, your or
[Docket No. FDA–2007–D–0133] DATES: Although you can comment on anyone else’s Social Security number, or
mstockstill on DSK3G9T082PROD with NOTICES
any guidance at any time (see 21 CFR confidential business information, such
Chronic Obstructive Pulmonary 10.115(g)(5)), to ensure that the Agency as a manufacturing process. Please note
Disease: Developing Drugs for considers your comment on this draft that if you include your name, contact
Treatment; Draft Guidance for guidance before it begins work on the information, or other information that
Industry; Availability
final version of the guidance, submit identifies you in the body of your
AGENCY: Food and Drug Administration, either electronic or written comments comments, that information will be
HHS. on the draft guidance by July 19, 2016. posted on http://www.regulations.gov.
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Document Created: 2016-05-20 01:59:22
Document Modified: 2016-05-20 01:59:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524. | |
| FR Citation | 81 FR 31944 |
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