7614 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site addresses in this reference 

section, but FDA is not responsible for 

any subsequent changes to the Web sites 

after this document publishes in the 

Federal Register.) 

1. FDA Center for Devices and Radiological 

Health, Letters to Industry Page, ‘‘Letter to 

Manufacturers of Enteral Feeding Tubes,’’ 

(http://www.fda.gov/downloads/

MedicalDevices/ResourcesforYou/Industry/

UCM218631.pdf). 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02802 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0288] 

Premarket Studies of Implantable 

Minimally Invasive Glaucoma Surgical 

Devices; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Premarket Studies of 

Implantable Minimally Invasive 

Glaucoma Surgical (MIGS) Devices.’’ 

This leap frog guidance document was 

developed to notify manufacturers of 

the recommended non-clinical and 

clinical studies to support a premarket 

approval application (PMA) for 

implantable MIGS devices. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 12, 2015. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Premarket Studies 

of Implantable Minimally Invasive 

Glaucoma Surgical (MIGS) Devices’’ to 

the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Tarver, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 66, Rm. 2504, Silver Spring, 

MD 20993–0002, 301–796–5620. 

SUPPLEMENTARY INFORMATION: 

I. Background 

When finalized, this draft guidance 

document will recommend non-clinical 

and clinical studies to support a PMA 

for implantable MIGS devices. 

Glaucoma is a progressive condition 

that damages the optic nerve of the eye, 

is associated with elevated intraocular 

pressure, and leads to irreversible vision 

loss. It is the second leading cause of 

visual disability and blindness in the 

world, with 1 in 40 adults over 40 years 

of age suffering from glaucoma having 

some visual loss. Current surgical 

treatments are aimed at reducing 

intraocular pressure (IOP) and often 

reserved for moderate to severe disease. 

During the past decade, novel medical 

devices, called MIGS devices, have 

emerged. These devices are designed to 

treat less severe glaucoma by enhancing 

physiological aqueous outflow with an 

approach that causes minimal ocular 

trauma. 

This draft guidance is a leap-frog 

guidance; leap frog guidances are 

intended to serve as a mechanism by 

which the Agency can share initial 

thoughts regarding the content of 

premarket submissions for emerging 

technologies and new clinical 

applications that are likely to be of 

public health importance very early in 

product development, generally before 

FDA has even received any such 

submissions. This leap-frog guidance 

represents the Agency’s initial thinking 

and our recommendations may change 

as more information becomes available. 

The Agency strongly encourages 

manufacturers to engage with the Center 

for Devices and Radiological Health 

(CDRH) through the Pre-Submission 

process to obtain more detailed 

feedback for implantable MIGS devices. 

For more information on PreSubmissions, please see ‘‘Requests for 

Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff’’ (http://

www.fda.gov/downloads/

MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/UCM311176.pdf). 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on implantable MIGS devices. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Premarket Studies of Implantable 

Minimally Invasive Glaucoma Surgical 

(MIGS) Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1400049 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

The guidance document ‘‘Premarket 

Studies of Implantable Minimally 

Invasive Glaucoma Surgical (MIGS) 

Devices’’ refers to previously approved 

information collections found in FDA 

regulations and guidance. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 814, subparts B and E are 

approved under OMB control number 

0910–0231 and the collections of 

information in the guidance document 

entitled ‘‘Requests for Feedback on 

Medical Device Submissions: The PreSubmission Program and Meetings with 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7615 

Food and Drug Administration Staff’’ 

are approved under OMB control 

number 0910–0756. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02722 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–M–0867, FDA– 

2014–M–0874, FDA–2014–M–0875, FDA– 

2014–M–1060, FDA–2014–M–1064, FDA– 

2014–M–1113, FDA–2014–M–1114, FDA– 

2014–M–1193, FDA–2014–M–1265, FDA– 

2014–M–1279, and FDA–2014–M–1280] 

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 

§ 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, 2014, through 

September 30, 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 JULY 1, 

2014, THROUGH SEPTEMBER 30, 2014 

PMA No., Docket No. Applicant Trade name Approval date 

P130021/S002, FDA–2014–M–0867 ..... Medtronic CoreValve LLC .................... Medtronic CoreValveTM System (MCS) June 12, 2014. 

P130009, FDA–2014–M–0874 .............. Edwards Lifesciences, LLC .................. Edwards SAPIEN XTTM Transcatheter 

Heart Valve and Accessories.

June 16, 2014. 

P130029, FDA–2014–M–0875 .............. Bard Peripheral Vascular, Inc ............... Fluency® Plus Endovascular Stent 

Graft.

June 17, 2014. 

P130011, FDA–2014–M–1064 .............. Sorin Group Canada, Inc ...................... Freedom SOLO Stentless Heart Valve 

and SOLO Smart Heart Valve.

June 24, 2014. 

P130030, FDA–2014–M–1060 .............. Boston Scientific Corp .......................... REBELTM Platinum Chromium Coronary Stent System (MonorailTM and 

Over-The-Wire).

June 27, 2014. 

P090029, FDA–2014–M–1113 .............. Medtronic Sofamor Danek USA, Inc .... Prestige® LP Cervical Disc ................... July 24, 2014. 

H130005, FDA–2014–M–1114 .............. MicroVention, Inc .................................. Low-Profile Visualized Intraluminal 

Support Device (LVIS and LVIS Jr.).

July 25, 2014. 

P130017, FDA–2014–M–1193 .............. Exact Sciences, Inc .............................. COLOGUARDTM ................................... August 11, 2014. 

H120003, FDA–2014–M–1265 .............. XVIVO Perfusion, Inc ............................ XVIVO Perfusion System (XPSTM) with 

STEEN SolutionTM Perfusate.

August 12, 2014. 

H130004, FDA–2014–M–1280 .............. Plexision, Inc ......................................... PleximmuneTM ...................................... August 26, 2014. 

P130020, FDA–2014–M–1279 .............. GE Healthcare ...................................... SenoClaire ............................................ August 26, 2014. 


tkelley on DSK3SPTVN1PROD with NOTICES