LIFEVEST (WCD 3000S) WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S005 · decided 2004-05-03
Approval details
- PMA number
- P010030
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST (WCD 3000S) WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2004-01-21
- Decision date
- 2004-05-03
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LIFEVEST WCD 3000 DEVICE TO BETTER FACILITATE SHORT-TERM USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3000S AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. THE LIFEVEST WCD 3000S SYSTEM IS INTENDED FOR SHORT-TERM USE IN A MEDICALLY SUPERVISED ENVIRONMENT. THE DEVICE IS NOT INTENDED TO BE WORN HOME.
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