[Federal Register Volume 61, Number 138 (Wednesday, July 17, 1996)]
[Notices]
[Pages 37277-37278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18071]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0238]


Schneider (USA) Inc.; Premarket Approval of WALLSTENT 
Transjugular Intrahepatic Portosystemic Shunt (TIPS) 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., Plymouth, MN, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the WALLSTENT TIPS Endoprosthesis. FDA's Center for 
Devices and Radiological Health (CDRH) notified the applicant, by 
letter of September 29, 1995, of the approval of the application.

DATES: Petitions for administrative review by August 16, 1996.

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: Dorothy B. Abel, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8262.

SUPPLEMENTARY INFORMATION: On October 4, 1994, Schneider (USA) Inc., 
Plymouth, MN 55442, submitted to CDRH an application for premarket 
approval of the WALLSTENT TIPS Endoprosthesis. The device is 
an endovascular stent and is indicated for creation of intrahepatic 
shunt connections between the portal venous system and the hepatic vein 
for prophylaxis of variceal bleeding in the treatment of portal 
hypertension and its complications in patients who have previously 
failed conventional treatment techniques.
    In accordance with the provisions of section 515(c)(2)(A) of the 
act (21 U.S.C. 360e(c)(2)(A)) as amended by the Safe Medical Devices 
Act of 1990, this premarket approval application (PMA) was not referred 
to the Circulatory System Devices Panel of the Medical Devices Advisory 
Committee, an FDA advisory committee. FDA concluded that the review by 
two outside review bodies was sufficient to identify the issues 
associated with the device and that sufficient guidance in the

[[Page 37278]]

evaluation of the safety and effectiveness had been provided by these 
review bodies. In addition, the safety and effectiveness of stents used 
for other indications has been the subject of four FDA advisory 
committee meetings.
    On September 29, 1995, 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.

Opportunity for Administrative Review

    Section 515(d)(3) of the act 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 Sec. 10.33(b)(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 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 August 16, 1996, 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: June 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-18071 Filed 7-16-96; 8:45 am]
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