WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
FDA premarket approval P010030 · decided 2001-12-18
Approval details
- PMA number
- P010030
- Trade name
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2001-05-04
- Decision date
- 2001-12-18
- Days to decision
- 228 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR THE WCD 2000 SYSTEM. THIS DEVICE 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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