LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S012 · decided 2008-11-14
Approval details
- PMA number
- P010030
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2008-09-15
- Decision date
- 2008-11-14
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR TWO NEW LITHIUM ION CELLS THAT ARE USED TO CONSTRUCT THE WCD 3000 BATTERY PACK.
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