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Brief Summary from the Circulatory System Devices Panel Meeting - July 28 & 29, 2004 |
(Corrected 8/5/2004)
A meeting of the Circulatory System Devices Panel was held on July 28, 2004. The Panel discussed, made recommendations, and voted on a premarket approval application supplement (P010012, Supplement 26) for the Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds).
The Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF = 35%) and QRS duration ?120ms.
Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (8-0) to approve with conditions a change to the Indications For Use for the previously approved Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). The conditions were:
A meeting of the Circulatory System Devices Panel was held on July 29, 2004. The Panel discussed and made recommendations on a premarket notification (K040904) for removal of the prescription requirement for the Philips HeartStart Home Defibrillator cleared in November 2002.
The Philips HeartStart Home Defibrillator is intended to be used to treat someone who the rescuer thinks may be a victim of sudden cardiac arrest. A person in sudden cardiac arrest:
The panel consensus was favorable for over the counter use of the device, while
suggesting specific labeling changes, particularly for pediatric use. The panel
also made recommendations regarding the tracking of users.
Contact: Geretta Wood, Executive Secretary,
(301) 443-8320, ext. 143; gpw@cdrh.fda.gov
Transcripts may be purchased from: (written requests only)
Neal R. Gross & Company
1323 Rhode Island Ave., NW
Washington, DC 20008
(202) 234-4433 (voice), (202) 387-7330 (fax)
Or
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500 (voice), (301) 443-1726 (fax)
Under normal circumstances, panel summary minutes are available 60-90 days
post meeting. Summaries are also available on the CDRH web site: http://www.fda.gov/cdrh/panel/index.html
CDRH Advisory Committee Database
Updated August 5, 2004
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