LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S042 · decided 2013-07-22
Approval details
- PMA number
- P010030
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2013-02-12
- Decision date
- 2013-07-22
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE WCD 4000 LIFEVEST® WEARABLE DEFIBRILLATOR AND THE SUBSEQUENT DISPLAY OF THAT INFORMATION ON THE SECURE LIFEVEST.
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