80 FR 58488 - 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 188 (September 29, 2015)

Page Range		58488-58489
FR Document		2015-24625

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 188 (Tuesday, September 29, 2015)

[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58488-58489]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-24625]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-2375, FDA-2015-M-0909, FDA-2015-M-0199, FDA-
2015-M-0200, FDA-2015-M-0201, FDA-2015-M-0228, FDA-2015-M-0266, FDA-
2015-M-0267, FDA-2015-M-0431, FDA-2015-M-0502, FDA-2015-M-0690, FDA-
2015-M-0738, FDA-2015-M-0910]

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: 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 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, 2015, through March 31,
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 January 1, 2015,
Through March 31, 2015
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P980040/S049, FDA-2014-M-2375....... Abbott Medical Optics, Inc.. TECNIS[supreg] multifocal 1- 12/17/2014
piece intraocular lens.
P140010, FDA-2015-M-0199............ Medtronic, Inc.............. IN.PACTTM AdmiralTM 12/30/2014
Paclitaxel-coated
Percutaneous Transluminal
Angioplasty Balloon
Catheter.
P130019, FDA-2015-M-0201............ EnteroMedics, Inc........... Maestro[supreg] Rechargeable 1/14/2015
System.
P130025, FDA-2015-M-0200............ Koning Corp................. Koning Breast CT (Model CBCT 1/14/2015
1000).
P060001/S020, FDA-2015-M-0228....... ev3, Inc.................... Prot[eacute]g[eacute]TM GPS 1/21/2015
Self-Expanding Peripheral
Stent System.
H140001, FDA-2015-M-0267............ ABIOMED, Inc................ Impella RP System........... 1/23/2015

[[Page 58489]]

P140017, FDA-2015-M-0266............ Medtronic, Inc.............. MelodyTM Transcatheter 1/27/2015
Pulmonary Valve (TPV) and
EnsembleTM Transcatheter
Valve Delivery System.
P130023, FDA-2015-M-0431............ Cohera Medical, Inc......... TissuGlu[supreg] Surgical 2/3/2015
Adhesive.
P010047/S036, FDA-2015-M-0502....... NeoMend, Inc................ ProGelTM Pleural Air Leak 2/13/2015
Sealant.
P140018, FDA-2015-M-0690............ Covidien, LLC............... VenaSealTM Closure System... 2/20/2015
H130001, FDA-2015-M-0909............ Biologics Consulting Group, Lixelle Beta 2-microglobulin 3/5/2015
Inc.. Apheresis Column.
P110024, FDA-2015-M-0738............ Advanced Circulatory ResQCPRTM System............ 3/6/2015
Systems, Inc..
P130013, FDA-2015-M-0910............ Boston Scientific Corp...... WATCHMANTM Left Atrial 3/13/2015
Appendage (LAA) Closure
Technology.
----------------------------------------------------------------------------------------------------------------

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: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24625 Filed 9-28-15; 8:45 am]
BILLING CODE 4164-01-P

58488 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices

not to submit an evaluation because the burden of these two data components Lane, Rm. 1061, Rockville, MD 20852.
field testing of a plant containing a new consists of the time it takes the company Please cite the appropriate docket
protein is conducted in such a way (e.g., to assemble the information on these number as listed in table 1 when
on such a small scale, or in such two data components and include it in submitting a written request. See the
isolated conditions, etc.) that cross- a NPC. We estimate that completing SUPPLEMENTARY INFORMATION section for
pollination with traditional crops or these data components will take about electronic access to the summaries of
commingling of plant material is not 16 hours per NPC. We estimate the safety and effectiveness.
likely to be an issue. Also, other reporting burden for the two other data FOR FURTHER INFORMATION CONTACT:
developers may have previously components to be 96 hours (16 hours × Melissa Torres, Center for Devices and
communicated with us about the food 6 responses). Thus, we estimate the total Radiological Health, Food and Drug
safety of a new plant protein, for annual hour burden for this collection Administration, 10903 New Hampshire
example, when the same protein was of information to be 120 hours. Ave., Bldg. 66, Rm. 1650, Silver Spring,
expressed in a different crop. Dated: September 23, 2015. MD 20993–0002, 301–796–5576.
For purposes of this extension
Leslie Kux, SUPPLEMENTARY INFORMATION:
request, we are re-evaluating our
estimate of the annual number of Associate Commissioner for Policy.
I. Background
responses that we expect to receive in [FR Doc. 2015–24620 Filed 9–28–15; 8:45 am]
the next 3 years. We received 12 NPCs BILLING CODE 4164–01–P In accordance with sections 515(d)(4)
during the 5-year period from 2005 and (e)(2) of the Federal Food, Drug, and
through 2009, for an average of 2.4 NPCs Cosmetic Act (the FD&C Act) (21 U.S.C.
per year. However, during the last DEPARTMENT OF HEALTH AND 360e(d)(4) and (e)(2)), notification of an
extension period, we saw a decrease in HUMAN SERVICES order approving, denying, or
the number of NPCs submitted by withdrawing approval of a PMA will
Food and Drug Administration continue to include a notice of
developers, with no NPCs submitted in
2010 through 2014. More recently, we [Docket Nos. FDA–2014–M–2375, FDA– opportunity to request review of the
received four NPCs in the first 4 months 2015–M–0909, FDA–2015–M–0199, FDA– order under section 515(g) of the FD&C
of 2015. Based on an approximate 2015–M–0200, FDA–2015–M–0201, FDA– Act. The 30-day period for requesting
average from the years 2005 through 2015–M–0228, FDA–2015–M–0266, FDA– reconsideration of an FDA action under
2015–M–0267, FDA–2015–M–0431, FDA– § 10.33(b) (21 CFR 10.33(b)) for notices
2009, and our experience in 2015, we
2015–M–0502, FDA–2015–M–0690, FDA– announcing approval of a PMA begins
are revising our estimate of the annual 2015–M–0738, FDA–2015–M–0910]
number of NPCs submitted by on the day the notice is placed on the
developers to be six or fewer. Medical Devices; Availability of Safety Internet. Section 10.33(b) provides that
The early food safety evaluation for and Effectiveness Summaries for FDA may, for good cause, extend this
new proteins includes six main data Premarket Approval Applications 30-day period. Reconsideration of a
components. Four of these data denial or withdrawal of approval of a
components are easily and quickly AGENCY: Food and Drug Administration, PMA may be sought only by the
obtainable, having to do with the HHS. applicant; in these cases, the 30-day
identity and source of the protein. We ACTION: Notice. period will begin when the applicant is
estimate that completing these data notified by FDA in writing of its
components will take about 4 hours per SUMMARY: The Food and Drug decision.
NPC. We estimate the reporting burden Administration (FDA) is publishing a The regulations provide that FDA
for the first four data components to be list of premarket approval applications publish a quarterly list of available
24 hours (4 hours × 6 responses). (PMAs) that have been approved. This safety and effectiveness summaries of
Two data components ask for original list is intended to inform the public of PMA approvals and denials that were
data to be generated. One data the availability of safety and announced during that quarter. The
component consists of a bioinformatics effectiveness summaries of approved following is a list of approved PMAs for
analysis which can be performed using PMAs through the Internet and the which summaries of safety and
publicly available databases. The other Agency’s Division of Dockets effectiveness were placed on the
data component involves ‘‘wet’’ lab Management. Internet from January 1, 2015, through
work to assess the new protein’s ADDRESSES: Submit written requests for March 31, 2015. There were no denial
stability and the resistance of the copies of summaries of safety and actions during this period. The list
protein to enzymatic degradation using effectiveness data to the Division of provides the manufacturer’s name, the
appropriate in vitro assays (protein Dockets Management (HFA–305), Food product’s generic name or the trade
digestibility study). The paperwork and Drug Administration, 5630 Fishers name, and the approval date.

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2015, THROUGH MARCH 31, 2015
PMA No., Docket No. Applicant Trade name Approval date

P980040/S049, FDA–2014–M–2375 ........ Abbott Medical Optics, Inc. ..................... TECNIS® multifocal 1-piece intraocular 12/17/2014
asabaliauskas on DSK5VPTVN1PROD with NOTICES

lens.
P140010, FDA–2015–M–0199 ................. Medtronic, Inc. ........................................ IN.PACTTM AdmiralTM Paclitaxel-coated 12/30/2014
Percutaneous Transluminal
Angioplasty Balloon Catheter.
P130019, FDA–2015–M–0201 ................. EnteroMedics, Inc. .................................. Maestro® Rechargeable System ............ 1/14/2015
P130025, FDA–2015–M–0200 ................. Koning Corp. ........................................... Koning Breast CT (Model CBCT 1000) .. 1/14/2015
P060001/S020, FDA–2015–M–0228 ........ ev3, Inc. .................................................. ProtégéTM GPS Self-Expanding Periph- 1/21/2015
eral Stent System.
H140001, FDA–2015–M–0267 ................. ABIOMED, Inc. ........................................ Impella RP System ................................. 1/23/2015

VerDate Sep<11>2014 17:54 Sep 28, 2015 Jkt 235001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1

Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices 58489

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2015, THROUGH MARCH 31, 2015—Continued
PMA No., Docket No. Applicant Trade name Approval date

P140017, FDA–2015–M–0266 ................. Medtronic, Inc. ........................................ MelodyTM Transcatheter Pulmonary 1/27/2015
Valve (TPV) and EnsembleTM
Transcatheter Valve Delivery System.
P130023, FDA–2015–M–0431 ................. Cohera Medical, Inc. ............................... TissuGlu® Surgical Adhesive .................. 2/3/2015
P010047/S036, FDA–2015–M–0502 ........ NeoMend, Inc. ......................................... ProGelTM Pleural Air Leak Sealant ........ 2/13/2015
P140018, FDA–2015–M–0690 ................. Covidien, LLC ......................................... VenaSealTM Closure System .................. 2/20/2015
H130001, FDA–2015–M–0909 ................. Biologics Consulting Group, Inc. ............ Lixelle Beta 2-microglobulin Apheresis 3/5/2015
Column.
P110024, FDA–2015–M–0738 ................. Advanced Circulatory Systems, Inc. ....... ResQCPRTM System .............................. 3/6/2015
P130013, FDA–2015–M–0910 ................. Boston Scientific Corp. ........................... WATCHMANTM Left Atrial Appendage 3/13/2015
(LAA) Closure Technology.

II. Electronic Access SUPPLEMENTARY INFORMATION: FDA is DEPARTMENT OF HEALTH AND
Persons with access to the Internet announcing the issuance of a priority HUMAN SERVICES
may obtain the documents at http:// review voucher to the sponsor of a rare
www.fda.gov/MedicalDevices/ pediatric disease product application. Food and Drug Administration
ProductsandMedicalProcedures/ Under section 529 of the FD&C Act (21 [Docket No. FDA–2015–N–3393]
DeviceApprovalsandClearances/ U.S.C. 360ff), which was added by
PMAApprovals/default.htm. FDASIA, FDA will award priority Determination That ORTHO EVRA
Dated: September 23, 2015. review vouchers to sponsors of rare (Norelgestromin/Ethinyl Estradiol)
pediatric disease product applications Transdermal System, 0.15 Milligrams/
Leslie Kux,
that meet certain criteria. FDA has 24 Hours Norelgestromin and 0.035
Associate Commissioner for Policy.
determined that Xuriden (uridine Milligrams/24 Hours Ethinyl Estradiol,
[FR Doc. 2015–24625 Filed 9–28–15; 8:45 am] Was Not Withdrawn From Sale for
BILLING CODE 4164–01–P
triacetate), manufactured by Wellstat
Therapeutics Corp., meets the criteria Reasons of Safety or Effectiveness
for a priority review voucher. Uridine AGENCY: Food and Drug Administration,
DEPARTMENT OF HEALTH AND triacetate is a pyrimidine analog for HHS.
HUMAN SERVICES uridine replacement. Xuriden is ACTION: Notice.
indicated for the treatment of hereditary
Food and Drug Administration orotic aciduria. Hereditary orotic SUMMARY: The Food and Drug
[Docket No. FDA–2014–N–0229] aciduria is caused by a deficiency in the Administration (FDA or Agency) has
activity of the pyrimidine pathway determined that ORTHO EVRA
Issuance of Priority Review Voucher; enzyme uridine 5′-monophosphate (norelgestromin/ethinyl estradiol)
Rare Pediatric Disease Product synthase. The disorder is generally Transdermal System, 0.15 milligrams
characterized by anemia and/or other (mg)/24 hours (hr) norelgestromin and
AGENCY: Food and Drug Administration,
hematological manifestations, excessive 0.035 mg/24hr ethinyl estradiol was not
HHS.
urinary excretion of orotic acid, failure withdrawn from sale for reasons of
ACTION: Notice. safety or effectiveness. This
to thrive, and developmental delay.
SUMMARY: The Food and Drug determination means that FDA will not
For further information about the Rare begin procedures to withdraw approval
Administration (FDA) is announcing the Pediatric Disease Priority Review
issuance of a priority review voucher to of abbreviated new drug applications
Voucher Program and for a link to the (ANDAs) that refer to this drug product,
the sponsor of a rare pediatric disease
full text of section 529 of the FD&C Act, and it will allow FDA to continue to
product application. The Federal Food,
go to http://www.fda.gov/ForIndustry/ approve ANDAs that refer to the
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug DevelopingProductsforRareDiseases product as long as they meet relevant
Administration Safety and Innovation Conditions/RarePediatricDiseasePriority legal and regulatory requirements.
Act (FDASIA), authorizes FDA to award VoucherProgram/default.htm. FOR FURTHER INFORMATION CONTACT:
priority review vouchers to sponsors of For further information about Xuriden Ayako Sato, Center for Drug Evaluation
rare pediatric disease product (uridine triacetate), go to the Drugs@ and Research, Food and Drug
applications that meet certain criteria. FDA Web site at http://www.accessdata. Administration, 10903 New Hampshire
FDA has determined that Xuriden fda.gov/scripts/cder/drugsatfda/ Ave., Bldg. 51, Rm. 6206, Silver Spring,
(uridine triacetate), manufactured by index.cfm. MD 20993–0002, 240–402–4191,
Wellstat Therapeutics Corp., meets the Ayako.Sato@fda.hhs.gov.
Dated: September 24, 2015.
criteria for a priority review voucher. SUPPLEMENTARY INFORMATION: In 1984,
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Leslie Kux,
FOR FURTHER INFORMATION CONTACT: Congress enacted the Drug Price
Larry Bauer, Rare Diseases Program, Associate Commissioner for Policy. Competition and Patent Term
Center for Drug Evaluation and [FR Doc. 2015–24640 Filed 9–28–15; 8:45 am] Restoration Act of 1984 (Public Law 98–
Research, Food and Drug BILLING CODE 4164–01–P 417) (the 1984 amendments), which
Administration, 10903 New Hampshire authorized the approval of duplicate
Ave., Silver Spring, MD 20993–0002, versions of drug products approved
301–796–4842, FAX: 301–796–9858, under an ANDA procedure. ANDA
larry.bauer@fda.hhs.gov. applicants must, with certain

VerDate Sep<11>2014 17:54 Sep 28, 2015 Jkt 235001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1

Document Created: 2015-12-15 09:46:18
Document Modified: 2015-12-15 09:46:18

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 58488

80 FR 58488 - 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 188 (September 29, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration