80 FR 72067 - 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 80, Issue 222 (November 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 222 (November 18, 2015)
| Page Range | 72067-72068 | |
| FR Document | 2015-29450 |
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)] [Notices] [Pages 72067-72068] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29450] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-M-1707, FDA-2015-M-2218, FDA-2015-M-2217, FDA- 2015-M-2497, FDA-2015-M-2219, FDA-2015-M-2499, FDA-2015-M-2634, FDA- 2015-M-2584, FDA-2015-M-2618, FDA-2015-M-2739, FDA-2015-M-2740, and FDA-2015-M-2964] 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-1707, FDA-2015-M-2218, FDA-2015-M-2217, FDA-2015-M-2497, FDA-2015-M-2219, FDA-2015-M-2499, FDA-2015-M-2634, FDA-2015-M-2584, FDA-2015-M-2618, FDA-2015-M-2739, FDA-2015-M-2740, and FDA-2015-M-2964 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: Melissa Torres, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-5576. 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 [[Page 72068]] 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 July 1, 2015, through September 30, 2015. 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 July 1, 2015, Through September 30, 2015 ---------------------------------------------------------------------------------------------------------------- Approval PMA No., docket No. Applicant Trade name date ---------------------------------------------------------------------------------------------------------------- P930016/S044, FDA-2015-M-1707............ AMO Manufacturing USA, LLC. STAR S4 IR Exciter Laser 5/6/2015 System and iDesign WaveScan Studio System. P120024, FDA-2015-M-2218................. Aesculap Implant Systems, activL[supreg] Artificial 6/11/2015 LLC. Disc. P140021, FDA-2015-M-2217................. Roche Diagnostics Elecsys[supreg] Anti-HCV II 6/11/2015 Operations, Inc. Immunoassay and Elecsys[supreg] PreciControl Anti-HCV. P140009, FDA-2015-M-2497................. St. Jude Medical Brio Neurostimulation 6/12/2015 Neuromodulation. System. P140025, FDA-2015-M-2219................. Ventana Medical Systems, VENTANA ALK (D5F3) CDx 6/12/2015 Inc. Assay. P140031, FDA-2015-M-2499................. Edwards Lifesciences, LLC.. SAPIEN 3\TM\ Transcatheter 6/17/2015 Heart Valve and Accessories. P040024/S073, FDA-2015-M-2634............ Galderma Laboratories L.P.. Restylane Lyft with 7/1/2015 Lidocaine. H080004, FDA-2015-M-2584................. Integrum AB................ Osseoanchored Prostheses 7/16/2015 for the Rehabilitation of Amputees (OPRA). P140028, FDA-2015-M-2618................. Boston Scientific Innova\TM\ Vascular Self- 7/21/2015 Corporation. Expanding Stent System. P140013, FDA-2015-M-2739................. Minerva Surgical, Inc...... Minerva\TM\ Endometrial 7/27/2015 Ablation System.. P140012, FDA-2015-M-2740................. ReShape Medical, Inc....... ReShape Integrated Dual 7/28/2015 Balloon System. P140008, FDA-2015-M-2964................. Apollo Endosurgery, Inc.... ORBERA\TM\ Intragastric 8/5/2015 Balloon System.. ---------------------------------------------------------------------------------------------------------------- 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: November 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29450 Filed 11-17-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices 72067
addition to data collection for the Agency’s Division of Dockets Submissions,’’ publicly viewable at
certification of QHPs, the reinsurance Management. http://www.regulations.gov or at the
and risk adjustment programs outlined ADDRESSES: You may submit comments Division of Dockets Management
by the Affordable Care Act, detailed in as follows: between 9 a.m. and 4 p.m., Monday
45 CFR part 153, as established by through Friday.
CMS–9975–F, Patient Protection and Electronic Submissions • Confidential Submissions—To
Affordable Care Act; Standards for Submit electronic comments in the submit a comment with confidential
Reinsurance, Risk Corridors, and Risk following way: information that you do not wish to be
Adjustment (77 FR 17220), published in • Federal eRulemaking Portal: http:// made publicly available, submit your
March 23, 2012, have general www.regulations.gov. Follow the comments only as a written/paper
information reporting requirements that instructions for submitting comments. submission. You should submit two
apply to issuers, group health plans, Comments submitted electronically, copies total. One copy will include the
third party administrators, and plan including attachments, to http:// information you claim to be confidential
offerings outside of the Exchanges. www.regulations.gov will be posted to with a heading or cover note that states
Subsequent regulations for these the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS
programs including the final HHS comment will be made public, you are CONFIDENTIAL INFORMATION’’. The
Notice of Benefit and Payment solely responsible for ensuring that your Agency will review this copy, including
Parameters for 2014 and the Program comment does not include any the claimed confidential information, in
Integrity: Exchange, Premium confidential information that you or a its consideration of comments. The
Stabilization Programs, and Market third party may not wish to be posted, second copy, which will have the
Standards; Amendments to the HHS such as medical information, your or claimed confidential information
Notice of Benefit and Payment anyone else’s Social Security number, or redacted/blacked out, will be available
Parameters for 2014 provide further confidential business information, such for public viewing and posted on
reporting requirements. Form Number: as a manufacturing process. Please note http://www.regulations.gov. Submit
CMS–10433 (OMB Control Number that if you include your name, contact both copies to the Division of Dockets
0938–1187); Frequency: Annually; information, or other information that Management. If you do not wish your
Affected Public: States and Private identifies you in the body of your name and contact information to be
Sector; Number of Respondents: 26,951; comments, that information will be made publicly available, you can
Number of Responses: 26,951; Total posted on http://www.regulations.gov. provide this information on the cover
Annual Hours: 235,153. (For questions • If you want to submit a comment sheet and not in the body of your
regarding this collection contact Leigha with confidential information that you comments and you must identify this
Basini at 301–492–4380.) do not wish to be made available to the information as ‘‘confidential.’’ Any
Dated: November 12, 2015. public, submit the comment as a information marked as ‘‘confidential’’
William N. Parham, III, written/paper submission and in the will not be disclosed except in
manner detailed (see ‘‘Written/Paper accordance with 21 CFR 10.20 and other
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory Submissions’’ and ‘‘Instructions’’). applicable disclosure law. For more
Affairs. information about FDA’s posting of
Written/Paper Submissions comments to public dockets, see 80 FR
[FR Doc. 2015–29343 Filed 11–17–15; 8:45 am]
Submit written/paper submissions as 56469, September 18, 2015, or access
BILLING CODE 4120–01–P
follows: the information at: http://www.fda.gov/
• Mail/Hand delivery/Courier (for regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND written/paper submissions): Division of default.htm.
HUMAN SERVICES Dockets Management (HFA–305), Food Docket: For access to the docket to
and Drug Administration, 5630 Fishers read background documents or the
Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments
• For written/paper comments received, go to http://
[Docket Nos. FDA–2015–M–1707, FDA– www.regulations.gov and insert the
2015–M–2218, FDA–2015–M–2217, FDA– submitted to the Division of Dockets
2015–M–2497, FDA–2015–M–2219, FDA– Management, FDA will post your docket number, found in brackets in the
2015–M–2499, FDA–2015–M–2634, FDA– comment, as well as any attachments, heading of this document, into the
2015–M–2584, FDA–2015–M–2618, FDA– except for information submitted, ‘‘Search’’ box and follow the prompts
2015–M–2739, FDA–2015–M–2740, and marked and identified, as confidential, and/or go to the Division of Dockets
FDA–2015–M–2964] if submitted as detailed in Management, 5630 Fishers Lane, Rm.
‘‘Instructions.’’ 1061, Rockville, MD 20852.
Medical Devices; Availability of Safety Instructions: All submissions received FOR FURTHER INFORMATION CONTACT:
and Effectiveness Summaries for must include the Docket Nos. FDA– Melissa Torres, Center for Devices and
Premarket Approval Applications 2015–M–1707, FDA–2015–M–2218, Radiological Health, Food and Drug
AGENCY: Food and Drug Administration, FDA–2015–M–2217, FDA–2015–M– Administration, 10903 New Hampshire
HHS. 2497, FDA–2015–M–2219, FDA–2015– Ave., Bldg. 66, Rm. 1650, Silver Spring,
ACTION: Notice. M–2499, FDA–2015–M–2634, FDA– MD 20993–0002, 301–796–5576.
2015–M–2584, FDA–2015–M–2618,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
SUMMARY: The Food and Drug FDA–2015–M–2739, FDA–2015–M–
Administration (FDA) is publishing a 2740, and FDA–2015–M–2964 for I. Background
list of premarket approval applications ‘‘Medical Devices; Availability of Safety In accordance with sections 515(d)(4)
(PMAs) that have been approved. This and Effectiveness Summaries for and (e)(2) of the Federal Food, Drug, and
list is intended to inform the public of Premarket Approval Applications.’’ Cosmetic Act (the FD&C Act) (21 U.S.C.
the availability of safety and Received comments will be placed in 360e(d)(4) and (e)(2)), notification of an
effectiveness summaries of approved the docket and, except for those order approving, denying, or
PMAs through the Internet and the submitted as ‘‘Confidential withdrawing approval of a PMA will
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![72068 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
continue to include a notice of denial or withdrawal of approval of a following is a list of approved PMAs for
opportunity to request review of the PMA may be sought only by the which summaries of safety and
order under section 515(g) of the FD&C applicant; in these cases, the 30-day effectiveness were placed on the
Act. The 30-day period for requesting period will begin when the applicant is Internet from July 1, 2015, through
reconsideration of an FDA action under notified by FDA in writing of its September 30, 2015. There were no
§ 10.33(b) (21 CFR 10.33(b)) for notices decision. denial actions during this period. The
announcing approval of a PMA begins The regulations provide that FDA list provides the manufacturer’s name,
on the day the notice is placed on the publish a quarterly list of available the product’s generic name or the trade
Internet. Section 10.33(b) provides that safety and effectiveness summaries of name, and the approval date.
FDA may, for good cause, extend this PMA approvals and denials that were
30-day period. Reconsideration of a announced during that quarter. The
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2015, THROUGH SEPTEMBER 30, 2015
Approval
PMA No., docket No. Applicant Trade name date
P930016/S044, FDA–2015–M–1707 ........ AMO Manufacturing USA, LLC ................ STAR S4 IR Exciter Laser System and 5/6/2015
iDesign WaveScan Studio System.
P120024, FDA–2015–M–2218 ................. Aesculap Implant Systems, LLC .............. activL® Artificial Disc ................................ 6/11/2015
P140021, FDA–2015–M–2217 ................. Roche Diagnostics Operations, Inc .......... Elecsys® Anti-HCV II Immunoassay and 6/11/2015
Elecsys® PreciControl Anti-HCV.
P140009, FDA–2015–M–2497 ................. St. Jude Medical Neuromodulation .......... Brio Neurostimulation System .................. 6/12/2015
P140025, FDA–2015–M–2219 ................. Ventana Medical Systems, Inc ................. VENTANA ALK (D5F3) CDx Assay ......... 6/12/2015
P140031, FDA–2015–M–2499 ................. Edwards Lifesciences, LLC ...................... SAPIEN 3TM Transcatheter Heart Valve 6/17/2015
and Accessories.
P040024/S073, FDA–2015–M–2634 ........ Galderma Laboratories L.P. ..................... Restylane Lyft with Lidocaine ................... 7/1/2015
H080004, FDA–2015–M–2584 ................. Integrum AB .............................................. Osseoanchored Prostheses for the Reha- 7/16/2015
bilitation of Amputees (OPRA).
P140028, FDA–2015–M–2618 ................. Boston Scientific Corporation ................... InnovaTM Vascular Self-Expanding Stent 7/21/2015
System.
P140013, FDA–2015–M–2739 ................. Minerva Surgical, Inc ................................ MinervaTM Endometrial Ablation System. 7/27/2015
P140012, FDA–2015–M–2740 ................. ReShape Medical, Inc .............................. ReShape Integrated Dual Balloon Sys- 7/28/2015
tem.
P140008, FDA–2015–M–2964 ................. Apollo Endosurgery, Inc ........................... ORBERATM Intragastric Balloon System. 8/5/2015
II. Electronic Access SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: In
Administration (FDA) is announcing compliance with 44 U.S.C. 3507, FDA
Persons with access to the Internet
that a proposed collection of has submitted the following proposed
may obtain the documents at http://
information has been submitted to the collection of information to OMB for
www.fda.gov/MedicalDevices/
Office of Management and Budget review and clearance.
ProductsandMedicalProcedures/
(OMB) for review and clearance under
DeviceApprovalsandClearances/ Guidance for Industry on Tropical
the Paperwork Reduction Act of 1995
PMAApprovals/default.htm. Disease Priority Review Vouchers—
(the PRA).
Dated: November 13, 2015. OMB Control Number 0910–NEW
DATES: Fax written comments on the
Leslie Kux, collection of information by December Section 1102 of the Food and Drug
Associate Commissioner for Policy. 18, 2015. Administration Amendments Act
[FR Doc. 2015–29450 Filed 11–17–15; 8:45 am] ADDRESSES: To ensure that comments on (FDAAA) adds new section 524 to the
BILLING CODE 4164–01–P the information collection are received, Federal Food, Drug, and Cosmetic Act
OMB recommends that written (the FD&C Act) (21 U.S.C. 360n).
comments be faxed to the Office of Section 524 is designed to encourage
DEPARTMENT OF HEALTH AND Information and Regulatory Affairs, development of new drug or biological
HUMAN SERVICES OMB, Attn: FDA Desk Officer, FAX: products for prevention and treatment
202–395–7285, or emailed to oira_ of certain tropical diseases affecting
Food and Drug Administration submission@omb.eop.gov. All millions of people throughout the world
comments should be identified with the and makes provisions for awarding
[Docket No. FDA–2008–D–0530] OMB control number 0910-New and priority review vouchers for future
title ‘‘Guidance for Industry on Tropical applications to sponsors of tropical
Agency Information Collection Disease Priority Review Vouchers.’’ disease products. By enacting section
Activities; Submission for Office of Also include the FDA docket number 524, Congress intended to stimulate new
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Management and Budget Review; found in brackets in the heading of this drug development for drugs to treat
Comment Request; Guidance for document. certain tropical diseases for which there
Industry on Tropical Disease Priority
FOR FURTHER INFORMATION CONTACT: FDA are no or few available treatments by
Review Vouchers
PRA Staff, Office of Operations, Food offering additional incentives for
AGENCY: Food and Drug Administration, and Drug Administration, 8455 obtaining FDA approval for
HHS. Colesville Rd., COLE–14526, Silver pharmaceutical treatments for these
Spring, MD 20993–0002, PRAStaff@ diseases. Under section 524, a sponsor
ACTION: Notice.
fda.hhs.gov. of a human drug application for a
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Document Created: 2018-03-01 11:20:31
Document Modified: 2018-03-01 11:20:31
| 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 | Melissa Torres, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-5576. | |
| FR Citation | 80 FR 72067 |
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