80 FR 22527 - 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 77 (April 22, 2015)

Page Range		22527-22528
FR Document		2015-09298

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.

Federal Register, Volume 80 Issue 77 (Wednesday, April 22, 2015)

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22527-22528]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-09298]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-1452, FDA-2014-M-1596, FDA-2014-M-1597, FDA-
2014-M-1599, FDA-2014-M-1735, FDA-2014-M-1736, FDA-2014-M-2042, FDA-
2014-M-2246, FDA-2014-M-2248, and FDA-2014-M-2376]

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: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the summaries of safety and
effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

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 October 1, 2014, through December 31,
2014. 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 October 1, 2014,
Through December 31, 2014
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P040037/S060, FDA-2014-M-1452........ W.L. Gore & Associates, GORE VIABAHN September 19, 2014.
Inc. Endoprosthesis, GORE
VIABAHN Endoprosthesis
with Heparin.
P070015/S122, FDA-2014-M-1596........ Abbott Vascular, Inc... XIENCE V[supreg] and October 3, 2014.
XIENCE nano[supreg]
Everolimus Eluting
Coronary Stent System.
P110019/S066, FDA-2014-M-1596........ Abbott Vascular, Inc... XIENCE PRIME[supreg] October 3, 2014.
and XIENCE PRIME LL
Everlimus Eluting
Coronary Stent System.
P130024, FDA-2014-M-1597............. Lutonix, Inc........... Lutonix 035 Drug Coated October 9, 2014.
Balloon PTA Catheter.
P110023/S007, FDA-2014-M-1599........ ev3, Inc............... EverFlexTM Self- October 10, 2014.
Expanding Peripheral
Stent System.
P120005/S018, FDA-2014-M-1735........ Dexcom, Inc............ Dexcom G4TM PLATINUM October 21, 2014.
Continuous Glucose
Monitoring System.
P130026, FDA-2014-M-1736............. St. Jude Medical....... TactiCath October 24, 2014.
Quartz[supreg]
Catheter and
TactiSysQuartz[supreg]
Equipment.
P120011, FDA-2014-M-2042............. Ideal Implant, Inc..... IDEAL IMPLANT[supreg] November 14, 2014.
Saline-filled Breast
Implant.
P130007, FDA-2014-M-2246............. Animas Corp............ Animas Vibe System..... November 25, 2014.
P140020, FDA-2014-M-2248............. Myriad Genetic BRACAnalysis CDxTM..... December 19, 2014.
Laboratories, Inc.
P020012/S009, FDA-2014-M-2376........ Suneva Medical, Inc.... Bellafill.............. December 23, 2014.
----------------------------------------------------------------------------------------------------------------

[[Page 22528]]

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: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09298 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22527

GuidanceCompliance list of premarket approval applications order approving, denying, or
RegulatoryInformation/Guidances/ (PMAs) that have been approved. This withdrawing approval of a PMA will
default.htm, http://www.fda.gov/ list is intended to inform the public of continue to include a notice of
BiologicsBloodVaccines/Guidance the availability of safety and opportunity to request review of the
ComplianceRegulatoryInformation/ effectiveness summaries of approved order under section 515(g) of the FD&C
default.htm, or http:// PMAs through the Internet and the Act. The 30-day period for requesting
www.regulations.gov. Agency’s Division of Dockets reconsideration of an FDA action under
Dated: April 16, 2015. Management. § 10.33(b) (21 CFR 10.33(b)) for notices
Leslie Kux, ADDRESSES: Submit written requests for announcing approval of a PMA begins
Associate Commissioner for Policy. copies of summaries of safety and on the day the notice is placed on the
[FR Doc. 2015–09303 Filed 4–21–15; 8:45 am] effectiveness data to the Division of Internet. Section 10.33(b) provides that
BILLING CODE 4164–01–P Dockets Management (HFA–305), Food FDA may, for good cause, extend this
and Drug Administration, 5630 Fishers 30-day period. Reconsideration of a
Lane, Rm. 1061, Rockville, MD 20852. denial or withdrawal of approval of a
DEPARTMENT OF HEALTH AND Please cite the appropriate docket PMA may be sought only by the
HUMAN SERVICES number as listed in table 1 when applicant; in these cases, the 30-day
submitting a written request. See the period will begin when the applicant is
Food and Drug Administration SUPPLEMENTARY INFORMATION section for notified by FDA in writing of its
[Docket Nos. FDA–2014–M–1452, FDA– electronic access to the summaries of decision.
2014–M–1596, FDA–2014–M–1597, FDA– safety and effectiveness. The regulations provide that FDA
2014–M–1599, FDA–2014–M–1735, FDA–
2014–M–1736, FDA–2014–M–2042, FDA–
FOR FURTHER INFORMATION CONTACT: publish a quarterly list of available
2014–M–2246, FDA–2014–M–2248, and Nicole Wolanski, Center for Devices and safety and effectiveness summaries of
FDA–2014–M–2376] Radiological Health, Food and Drug PMA approvals and denials that were
Administration, 10903 New Hampshire announced during that quarter. The
Medical Devices; Availability of Safety Ave., Bldg. 66, Rm. 1650, Silver Spring, following is a list of approved PMAs for
and Effectiveness Summaries for MD 20993–0002, 301–796–6570. which summaries of safety and
Premarket Approval Applications SUPPLEMENTARY INFORMATION: effectiveness were placed on the
AGENCY: Food and Drug Administration, Internet from October 1, 2014, through
I. Background December 31, 2014. There were no
HHS.
ACTION: Notice. In accordance with sections 515(d)(4) denial actions during this period. The
and (e)(2) of the Federal Food, Drug, and list provides the manufacturer’s name,
SUMMARY: The Food and Drug Cosmetic Act (the FD&C Act) (21 U.S.C. the product’s generic name or the trade
Administration (FDA) is publishing a 360e(d)(4) and (e)(2)), notification of an name, and the approval date.

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2014, THROUGH DECEMBER 31, 2014
PMA No., Docket No. Applicant Trade name Approval date

P040037/S060, FDA–2014–M–1452 ............... W.L. Gore & Associ- GORE VIABAHN Endoprosthesis, GORE September 19, 2014.
ates, Inc. VIABAHN Endoprosthesis with Heparin.
P070015/S122, FDA–2014–M–1596 ............... Abbott Vascular, Inc ... XIENCE V® and XIENCE nano® Everolimus October 3, 2014.
Eluting Coronary Stent System.
P110019/S066, FDA–2014–M–1596 ............... Abbott Vascular, Inc ... XIENCE PRIME® and XIENCE PRIME LL October 3, 2014.
Everlimus Eluting Coronary Stent System.
P130024, FDA–2014–M–1597 ......................... Lutonix, Inc ................. Lutonix 035 Drug Coated Balloon PTA Cath- October 9, 2014.
eter.
P110023/S007, FDA–2014–M–1599 ............... ev3, Inc ....................... EverFlexTM Self-Expanding Peripheral Stent October 10, 2014.
System.
P120005/S018, FDA–2014–M–1735 ............... Dexcom, Inc ............... Dexcom G4TM PLATINUM Continuous Glu- October 21, 2014.
cose Monitoring System.
P130026, FDA–2014–M–1736 ......................... St. Jude Medical ........ TactiCath Quartz® Catheter and October 24, 2014.
TactiSysQuartz® Equipment.
P120011, FDA–2014–M–2042 ......................... Ideal Implant, Inc ........ IDEAL IMPLANT® Saline-filled Breast Implant November 14, 2014.
P130007, FDA–2014–M–2246 ......................... Animas Corp .............. Animas Vibe System ....................................... November 25, 2014.
P140020, FDA–2014–M–2248 ......................... Myriad Genetic Lab- BRACAnalysis CDxTM .................................... December 19, 2014.
oratories, Inc.
P020012/S009, FDA–2014–M–2376 ............... Suneva Medical, Inc ... Bellafill ............................................................. December 23, 2014.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

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22528 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices

II. Electronic Access drug product, animal drug product, new drug application became effective
Persons with access to the Internet medical device, food additive, or color was on July 13, 2005.
may obtain the documents at http:// additive) was subject to regulatory 2. The date the application was
www.fda.gov/MedicalDevices/ review by FDA before the item was initially submitted with respect to the
ProductsandMedicalProcedures/ marketed. Under these acts, a product’s human drug product under section
DeviceApprovalsandClearances/ regulatory review period forms the basis 505(b) of the FD&C Act: May 29, 2012.
PMAApprovals/default.htm. for determining the amount of extension FDA has verified the applicant’s claim
an applicant may receive. that the new drug application (NDA) for
Dated: April 16, 2015. A regulatory review period consists of
Leslie Kux, COMETRIQ (NDA 203756) was
two periods of time: A testing phase and submitted on May 29, 2012.
Associate Commissioner for Policy. an approval phase. For human drug
[FR Doc. 2015–09298 Filed 4–21–15; 8:45 am] products, the testing phase begins when 3. The date the application was
BILLING CODE 4164–01–P the exemption to permit the clinical approved: November 29, 2012. FDA has
investigations of the drug becomes verified the applicant’s claim that NDA
effective and runs until the approval 203756 was approved on November 29,
DEPARTMENT OF HEALTH AND phase begins. The approval phase starts 2012.
HUMAN SERVICES with the initial submission of an This determination of the regulatory
application to market the human drug review period establishes the maximum
Food and Drug Administration product and continues until FDA grants potential length of a patent extension.
[Docket No. FDA–2014–E–0131] permission to market the drug product. However, the USPTO applies several
Although only a portion of a regulatory statutory limitations in its calculations
Determination of Regulatory Review review period may count toward the of the actual period for patent extension.
Period for Purposes of Patent actual amount of extension that the In its application for patent extension,
Extension; COMETRIQ Director of USPTO may award (for this applicant seeks 688 days of patent
AGENCY: Food and Drug Administration, example, half the testing phase must be term extension.
HHS. subtracted as well as any time that may
Anyone with knowledge that any of
have occurred before the patent was
ACTION: Notice. the dates as published are incorrect may
issued), FDA’s determination of the
submit to the Division of Dockets
SUMMARY: The Food and Drug length of a regulatory review period for
Management (see ADDRESSES) either
Administration (FDA) has determined a human drug product will include all
electronic or written comments and ask
the regulatory review period for of the testing phase and approval phase
for a redetermination by June 22, 2015.
COMETRIQ and is publishing this as specified in 35 U.S.C. 156(g)(1)(B).
Furthermore, any interested person may
notice of that determination as required FDA has approved for marketing the
petition FDA for a determination
by law. FDA has made the human drug product COMETRIQ
regarding whether the applicant for
determination because of the (cabozanitinib (S)-maleate). COMETRIQ
extension acted with due diligence
submission of an application to the is indicated for the treatment of patients
during the regulatory review period by
Director of the U.S. Patent and with progressive, metastatic medullary
October 19, 2015. To meet its burden,
Trademark Office (USPTO), Department thyroid cancer. Subsequent to this
the petition must contain sufficient facts
of Commerce, for the extension of a approval, the USPTO received a patent
term restoration application for to merit an FDA investigation. (See H.
patent which claims that human drug Rept. 857, part 1, 98th Cong., 2d sess.,
product. COMETRIQ (U.S. Patent No. 7,579,473)
from Exelixis, Incorporated, and the pp. 41–42, 1984.) Petitions should be in
ADDRESSES: Submit electronic USPTO requested FDA’s assistance in the format specified in 21 CFR 10.30.
comments to http:// determining this patent’s eligibility for Interested persons may submit to the
www.regulations.gov. Submit written patent term restoration. In a letter dated Division of Dockets Management (see
petitions (two copies are required) and March 27, 2014, FDA advised the ADDRESSES) electronic or written
written comments to the Division of USPTO that this human drug product comments and written or electronic
Dockets Management (HFA–305), Food had undergone a regulatory review petitions. It is only necessary to send
and Drug Administration, 5630 Fishers period and that the approval of one set of comments. Identify comments
Lane, Rm. 1061, Rockville, MD 20852. COMETRIQ represented the first with the docket number found in
Submit petitions electronically to permitted commercial marketing or use brackets in the heading of this
http://www.regulations.gov at Docket of the product. Thereafter, the USPTO document. If you submit a written
No. FDA–2013–S–0610. requested that FDA determine the petition, two copies are required. A
FOR FURTHER INFORMATION CONTACT: product’s regulatory review period. petition submitted electronically must
Beverly Friedman, Office of FDA has determined that the be submitted to http://
Management, Food and Drug applicable regulatory review period for www.regulations.gov, Docket No. FDA–
Administration, 10001 New Hampshire COMETRIQ is 2,698 days. Of this time, 2013–S–0610. Comments and petitions
Ave., Hillandale Campus, Rm. 3180, 2,513 days occurred during the testing that have not been made publicly
Silver Spring, MD 20993, 301–796– phase of the regulatory review period, available on http://www.regulations.gov
7900. while 185 days occurred during the may be viewed in the Division of
asabaliauskas on DSK5VPTVN1PROD with NOTICES

SUPPLEMENTARY INFORMATION: The Drug approval phase. These periods of time Dockets Management between 9 a.m.
Price Competition and Patent Term were derived from the following dates: and 4 p.m., Monday through Friday.
Restoration Act of 1984 (Pub. L. 98–417) 1. The date an exemption under Dated: April 16, 2015.
and the Generic Animal Drug and Patent section 505(i) of the Federal Food, Drug,
Leslie Kux,
Term Restoration Act (Pub. L. 100–670) and Cosmetic Act (the FD&C Act) (21
generally provide that a patent may be U.S.C. 355(i)) became effective: July 13, Associate Commissioner for Policy.
extended for a period of up to 5 years 2005. FDA has verified the applicant’s [FR Doc. 2015–09302 Filed 4–21–15; 8:45 am]
so long as the patented item (human claim that the date the investigational BILLING CODE 4164–01–P

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Document Created: 2015-12-16 08:28:15
Document Modified: 2015-12-16 08:28:15

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		Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301- 796-6570.
FR Citation		80 FR 22527

80 FR 22527 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 77 (April 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration