LIFEVEST WCD 3000 SYSTEM
FDA premarket approval P010030/S001 · decided 2002-10-09
Approval details
- PMA number
- P010030
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WCD 3000 SYSTEM
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2002-02-07
- Decision date
- 2002-10-09
- Days to decision
- 244 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE WCD MONITOR (P010030/S001) AND ELECTRODE BELT/CHEST GARMENT SYSTEM (P010030/S003). THE SYSTEM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3000 SYSTEM AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND EITHER ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
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