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:
- The removal of the decrease in all-cause hospitalization from the Indications for Use and
- The addition of a summary of the all-cause hospitalization data to be included in the Clinical Study section of the Instructions For Use.
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:
- does not respond when shaken, and
- is not breathing normally.
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.
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