[Federal Register Volume 62, Number 35 (Friday, February 21, 1997)]
[Notices]
[Pages 8025-8026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0054]


Schneider (USA), Inc.; Premarket Approval of WALLSTENT 
Iliac Endoprosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Schneider (USA), Inc., Minneapolis, MN, 
for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
(the act), of the WALLSTENT Iliac Endoprosthesis. After 
reviewing the recommendation of the Circulatory System Devices Panel, 
FDA's Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of May 28, 1996, of the approval of the 
application. In addition, the WALLSTENT Iliac Endoprosthesis 
requires tracking under the act as amended by the Safe Medical Devices 
Act of 1990.

DATES: Petitions for administrative review by March 24, 1997.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Judy J. Danielson, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8243.

SUPPLEMENTARY INFORMATION: On June 9, 1994, Schneider (USA), Inc., 
Minneapolis, MN 55432, submitted to CDRH an application for premarket 
approval of the WALLSTENT Iliac Endoprosthesis. The device is 
a peripheral stent and is indicated for use following suboptimal 
percutaneous transluminal angioplasty (PTA) of common and/or external 
iliac artery stenotic lesions, which are less than or equal to 10 
centimeters in length. A suboptimal PTA is defined as a technically 
successful dilation, judged by the physician to be suboptimal due to 
the presence of unfavorable lesion morphology such as: An inadequate 
angiographic and/or hemodynamic result as defined by a 30 percent or 
greater residual stenosis after PTA, lesion recoil, or intimal flaps; 
flow limiting dissections post PTA longer than the initial lesion 
length; or a 5 mmHg or greater mean transtenotic pressure gradient post 
PTA.

[[Page 8026]]

    On March 4, 1996, the Circulatory System Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the application. On May 28, 1996, CDRH 
approved the application by a letter to the applicant from the Director 
of the Office of Device Evaluation, CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.
    Under section 519(e) of the act (21 U.S.C. 360i(e)) as amended by 
the Safe Medical Devices Act of 1990, manufacturers of certain types of 
devices are required to adopt a method of tracking that follows the 
devices through the distribution chain and then identifies and follows 
the patients who receive them. FDA has identified the above device as a 
new generic type of device requiring tracking. FDA is providing a 30-
day period for interested persons to submit to the Dockets Management 
Branch (address above) written comments regarding the agency's position 
that this new generic type of device requires tracking.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under part 12 (21 CFR 
part 12) of FDA's administrative practices and procedures regulations 
or a review of the application and CDRH's action by an independent 
advisory committee of experts. A petition is to be in the form of a 
petition for reconsideration under 21 CFR 10.33(b). A petitioner shall 
identify the form of review requested (hearing or independent advisory 
committee) and shall submit with the petition supporting data and 
information showing that there is a genuine and substantial issue of 
material fact for resolution through administrative review. After 
reviewing the petition, FDA will decide whether to grant or deny the 
petition and will publish a notice of its decision in the Federal 
Register. If FDA grants the petition, the notice will state the issue 
to be reviewed, the form of the review to be used, the persons who may 
participate in the review, the time and place where the review will 
occur, and other details.
    Petitioners may, at any time on or before March 24, 1997, file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h), (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: January 16, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-4228 Filed 2-20-97; 8:45 am]
BILLING CODE 4160-01-F