[Federal Register Volume 59, Number 240 (Thursday, December 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30868]


[[Page Unknown]]

[Federal Register: December 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0402]

 

Endosonics Corp.; Premarket Approval of the Endosonics 
OracleTM Micro PTCA Catheter

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 Endosonics Corp., Rancho Cordova, CA, 
for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
(the act), of the Endosonics OracleTM Micro PTCA Catheter. 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 September 30, 1994, of the approval of the 
application.

DATES: Petitions for administrative review by January 17, 1995.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

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

SUPPLEMENTARY INFORMATION: On December 26, 1991, Endosonics Corp., 
3078-B Prospect Park Dr., Rancho Cordova, CA 95670, submitted to CDRH 
an application for premarket approval of the Endosonics OracleTM 
Micro PTCA Catheter. The device is a percutaneous transluminal coronary 
angioplasty (PTCA) dilatation catheter and is indicated for use in 
patients with coronary artery disease who are acceptable candidates for 
coronary artery bypass graft surgery, and who meet one of the following 
selection criteria: (1) Single vessel atherosclerotic coronary artery 
disease that is discrete and accessible to a dilatation catheter; (2) 
multiple vessel coronary artery disease under certain circumstances; 
and (3) coronary artery disease of the native coronary arteries and/or 
coronary artery bypass grafts of some patients who have previously 
undergone coronary artery bypass graft surgery, who have recurrence of 
symptoms, and progression of disease or stenosis and closure of the 
grafts.
    The Endosonics OracleTM Micro PTCA Catheter is further 
indicated for use following balloon dilatation as an adjunct to 
conventional angiographic procedures to provide: (1) An image of the 
vessel lumen and wall structures, and (2) dimensional measurements from 
the image.
    On April 12, 1993, the Circulatory System Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended disapproval of the application, with specific 
requirements to make the application approvable. The sponsor has 
submitted the required information. On September 30, 1994, 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 (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 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 January 17, 1995, 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: December 5, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-30868 Filed 12-14-94; 8:45 am]
BILLING CODE 4160-01-F