[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]
BILLING CODE 4160-01-F
