[Federal Register Volume 61, Number 238 (Tuesday, December 10, 1996)]
[Notices]
[Page 65070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0473]


Medirex, Inc.; Premarket Approval of the Tripter-X1 Series 
Extracorporeal Shock Wave Lithotripters (Tripter-X1, Tripter-X1 Nova, 
and Tripter-X1 Compact)

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 Medirex, Inc., Wellesley Hills, MA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the Tripter-X1 Series Extracorporeal Shock Wave Lithotripters 
(Tripter-X1, Tripter-X1 Nova, and Tripter-X1 Compact). FDA's Center for 
Devices and Radiological Health (CDRH) notified the applicant, by 
letter of September 20, 1996, of the approval of the application.

DATES: Petitions for administrative review by January 9, 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: Russell P. Pagano, Center for Devices 
and Radiological Health (HFZ-472), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION: On September 29, 1993, Medirex, Inc., 
Wellesley Hills, MA 02181, submitted to CDRH an application for 
premarket approval of the Tripter-X1 Series Extracorporeal Shock Wave 
Lithotripters (Tripter-X1, Tripter-X1 Nova, and Tripter-X1 Compact). 
These devices are indicated for use in the fragmentation of urinary 
tract stones (i.e., renal calyceal, renal pelvic, and upper ureteral 
stones).
    In accordance with the provisions of section 515(c)(2) of the act 
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of 
1990 (Pub. L. 101-629), this premarket approval application (PMA) was 
not referred to the Gastroenterology and Urology Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory panel, for review 
and recommendation because the information in the PMA substantially 
duplicates information previously reviewed by this panel.
    On September 20, 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.

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 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 January 9, 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: October 24, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-31359 Filed 12-9-96; 8:45 am]
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