[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
