80 FR 60393 - 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 193 (October 6, 2015)

Page Range		60393-60394
FR Document		2015-25352

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 193 (Tuesday, October 6, 2015)

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60393-60394]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-25352]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-1064, FDA-2015-M-1065, FDA-2015-M-1177, FDA-
2015-M-1178, FDA-2015-M-1325, FDA-2015-M-1326, FDA-2015-M-1460, FDA-
2015-M-1461, FDA-2015-M-1557, FDA-2015-M-1708, FDA-2015-M-1709, FDA-
2015-M-1956, FDA-2015-M-1957, FDA-2015-M-1958, FDA-2015-M-1959, FDA-
2015-M-2077, FDA-2015-M-2078, FDA-2014-M-2247]

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

[[Page 60394]]

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 April 1, 2015, through June 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 April 1, 2015 Through
June 30, 2015
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P140003, FDA-2015-M-1177.............. ABIOMED, Inc............. Impella[supreg] 2.5 System... 3/23/2015
P130014, FDA-2015-M-1065.............. HyperBranch Medical Adherus[supreg] AutoSpray 3/30/2015
Technology, Inc. Dural Sealant.
P130021/S010, FDA-2015-M-1064......... Medtronic CoreValve, LLC. Medtronic CoreValve[supreg] 3/30/2015
System.
P110015, FDA-2015-M-1178.............. Advanced Breath Gastric Emptying Breath Test 4/6/2015
Diagnostics, LLC. (GEBT).
P040020/S050, FDA-2015-M-1325......... Alcon Research, Ltd...... AcrySof IQ ReSTOR +2.5 D 4/13/2015
Multifocal Intraocular Lens.
P120023, FDA-2015-M-1326.............. AcuFocusTM, Inc.......... KAMRATM inlay................ 4/17/2015
H130007, FDA-2014-M-2247.............. CVRx[supreg], Inc........ Barostim neoTM Legacy System. 12/12/2014
P140011, FDA-2015-M-1460.............. Siemens Medical Solutions MAMMOMAT Inspiration with 4/21/2015
USA, Inc. Tomosynthesis Option.
P120017, FDA-2015-M-1461.............. Medtronic, Inc........... Model 5071 Lead.............. 4/27/2015
P130012, FDA-2015-M-1557.............. Greatbatch Medical....... Myopore Sutureless Myocardial 4/30/2015
Pacing Lead.
P140023, FDA-2015-M-1708.............. Roche Molecular Systems, cobas[supreg] KRAS Mutation 5/7/2015
Inc. Test.
P130022, FDA-2015-M-1709.............. Nevro Corp............... Nevro Senza Spinal Cord 5/8/2015
Stimulation (SCS) System.
P140026, FDA-2015-M-1956.............. Silk Road Medical, Inc... ENROUTETM Transcarotid Stent 5/18/2015
System.
P140004, FDA-2015-M-1957.............. Vertiflex[supreg], Inc... Superion[supreg] InterSpinous 5/20/2015
Spacer.
P140002, FDA-2015-M-1958.............. Terumo Medical Corp...... Misago[supreg] Peripheral 5/22/2015
Self-expanding Stent System.
P120005/S031, FDA-2015-M-1959......... Dexcom, Inc.............. Dexcom G4[supreg]PLATINUM 5/22/2015
(Pediatric) Continuous
Glucose Monitoring System.
P110010/S096, FDA-2015-M-2077......... Boston Scientific Corp... PROMUS[supreg] ElementTM Plus 6/1/2015
and Promus PREMIERTM
Everolimus-Eluting Platinum
Chromium Coronary Stent
System (MonorailTM and Over-
the-Wire).
P050052/S049, FDA-2015-M-2078......... Merz North America....... Radiesse[supreg] Injectable 6/4/2015
Implant.
----------------------------------------------------------------------------------------------------------------

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 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25352 Filed 10-5-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60393

B. REMS Data Elements www.fda.gov/ForIndustry/ DEPARTMENT OF HEALTH AND
For REMS with ETASU, the REMS DataStandards/ HUMAN SERVICES
data elements describe REMS StructuredProductLabeling/
requirements using a standardized, ucm189651.htm), to make available free Food and Drug Administration
machine-readable format that permits SPL authoring software that SPL authors [Docket Nos. FDA–2015–M–1064, FDA–
integration of REMS information into may use to create new SPL documents 2015–M–1065, FDA–2015–M–1177, FDA–
electronic health information or edit previous versions. 2015–M–1178, FDA–2015–M–1325, FDA–
technology, including clinical decision After the SPL is created, the 2015–M–1326, FDA–2015–M–1460, FDA–
support, e-Prescribing systems, and 2015–M–1461, FDA–2015–M–1557, FDA–
participant would upload the file 2015–M–1708, FDA–2015–M–1709, FDA–
electronic pharmacy systems. FDA has through the ESG. The Internet portal can 2015–M–1956, FDA–2015–M–1957, FDA–
developed terminology to assist in the be found at http://www.fda.gov/ 2015–M–1958, FDA–2015–M–1959, FDA–
coding of REMS data elements. This ForIndustry/ 2015–M–2077, FDA–2015–M–2078, FDA–
terminology is available as part of the ElectronicSubmissionsGateway/ 2014–M–2247]
Draft REMS SPL Implementation Guide default.htm. Prior to uploading an SPL
Excerpt on FDA’s SPL Web site (http:// file, one must obtain a digital certificate. Medical Devices; Availability of Safety
www.fda.gov/ForIndustry/ Instructions regarding obtaining a and Effectiveness Summaries for
DataStandards/ digital certificate used with FDA’s ESG Premarket Approval Applications
StructuredProductLabeling/
and uploading the SPL file for AGENCY: Food and Drug Administration,
default.htm). The REMS Data Elements
submission can be found at http:// HHS.
do not replace the approved REMS
www.fda.gov/esg/default.htm. The ACTION: Notice.
document, which will continue to be
the enforceable document establishing digital certificate binds together the
owner’s name and a pair of electronic SUMMARY: The Food and Drug
the REMS requirements.
keys (a public and a private key) that Administration (FDA) is publishing a
III. How To Participate in the REMS can be used to encrypt and sign list of premarket approval applications
SPL Pilot documents. A fee of up to (PMAs) that have been approved. This
A. Participation approximately $20 is charged for the list is intended to inform the public of
digital certificate. Application holders the availability of safety and
Volunteers interested in participating should have already secured a digital effectiveness summaries of approved
in the pilot should contact pilot staff by certificate because they are required to PMAs through the Internet and the
email at REMS_Standardization@ Agency’s Division of Dockets
do so when they register and list.
fda.hhs.gov. The following information Management.
should be included in the request: During the pilot, FDA staff will be
Contact name, contact phone number, available to answer any questions or ADDRESSES: Submit written requests for
and contact email address. FDA will concerns that may arise. Pilot copies of summaries of safety and
contact interested applicants to discuss participants will be asked to comment effectiveness data to the Division of
the pilot. FDA is seeking a limited on and discuss their experiences Dockets Management (HFA–305), Food
number of participants (no more than converting their REMS into SPL format. and Drug Administration, 5630 Fishers
nine) to participate in this pilot. FDA is Their comments are expected to assist Lane, Rm. 1061, Rockville, MD 20852.
also seeking comment from any FDA in its completion of the REMS SPL Please cite the appropriate docket
stakeholder on its proposed approach project. number as listed in table 1 when
for capturing REMS information in SPL submitting a written request. See the
IV. Duration of the REMS SPL Pilot SUPPLEMENTARY INFORMATION section for
format in this pilot, as described in
section II. electronic access to the summaries of
FDA will accept requests for safety and effectiveness.
B. Procedures participation in the REMS SPL pilot
FOR FURTHER INFORMATION CONTACT:
from October 6, 2015 to December 7,
To create an SPL file and submit it to Melissa Torres, Center for Devices and
2015. The pilot will proceed for 4
FDA, a participant will need the Radiological Health, Food and Drug
months, from October 6, 2015 to Administration, 10903 New Hampshire
following tools: Appropriate software,
February 3, 2016. This pilot may be Ave., Bldg. 66, Rm. 1650, Silver Spring,
knowledge of terminology and
standards, and access to FDA’s extended as resources and needs allow. MD 20993–0002, 301–796–5576.
Electronic Submissions Gateway (ESG) V. Paperwork Reduction Act of 1995 SUPPLEMENTARY INFORMATION:
(http://www.fda.gov/ForIndustry/
ElectronicSubmissionsGateway/ This notice refers to previously I. Background
default.htm). The ESG is an Agency- approved collections of information In accordance with sections 515(d)(4)
wide means of accepting electronic found in FDA regulations. These and (e)(2) of the Federal Food, Drug, and
regulatory submissions. The FDA ESG collections of information are subject to Cosmetic Act (the FD&C Act) (21 U.S.C.
enables the secure submission of review by the Office of Management and 360e(d)(4) and (e)(2)), notification of an
regulatory submissions. Instructions and Budget (OMB) under the Paperwork order approving, denying, or
information regarding the creation of an Reduction Act of 1995 (44 U.S.C. 3501– withdrawing approval of a PMA will
SPL file and the converting of REMS 3520). The collections of information in continue to include a notice of
information into SPL can be found at 21 CFR part 314 have been approved opportunity to request review of the
tkelley on DSK3SPTVN1PROD with NOTICES

http://www.fda.gov/ForIndustry/ under OMB control number 0910–0001. order under section 515(g) of the FD&C
DataStandards/ Dated: September 30, 2015. Act. The 30-day period for requesting
StructuredProductLabeling/default.htm. reconsideration of an FDA action under
Leslie Kux,
There should be no additional cost § 10.33(b) (21 CFR 10.33(b)) for notices
associated with obtaining the software. Associate Commissioner for Policy. announcing approval of a PMA begins
In 2010, FDA collaborated with [FR Doc. 2015–25349 Filed 10–5–15; 8:45 am] on the day the notice is placed on the
Pragmatic Data, LLC (http:// BILLING CODE 4164–01–P Internet. Section 10.33(b) provides that

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Document Created: 2015-12-15 08:51:10
Document Modified: 2015-12-15 08:51:10

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 60393

80 FR 60393 - 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 193 (October 6, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration