Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Advisory Committees

Summary from the Circulatory System Devices Panel Meeting - March 6, 2003

A meeting of the Circulatory System Devices Panel was held on March 6, 2003. The Panel discussed, made recommendations, and voted on a premarket approval application for Cryocath Technologies 7F Freezor Cardiac Cryoablation Catheter (P020045). The device is intended for cryoablation of cardiac tissue to treat patients with atrioventricular node reentrant tachycardia (AVNRT) and for mapping of the atrioventricular node. Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (7-3) that the application be found ‘approvable with conditions’. The Panel’s conditions included striking mapping of the atrioventricular node from the intended use of the device, establishing a formal training program as part of the approval, postmarket evaluation to monitor for occurrence of AV block, and a minor modification to the contraindications section of the labeling to warn against the use in patients with cryoglobulinemia.

Contact: Geretta Wood, Executive Secretary,
(301) 443-8320 ext. 143,

Transcripts may be purchased from: (written requests only)
Neal Gross & Company
1323 Rhode Island Ave., NW
Washington, DC 20008
(202)234-4433 (voice), (202)387-7330 (fax)
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500 (voice), (301) 332-1726 (fax)

Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.

CDRH Advisory Committee Database

Page Last Updated: 08/05/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English