LIFEVEST WAERABLE DEFIBRILLATOR
FDA premarket approval P010030/S031 · decided 2012-11-02
Approval details
- PMA number
- P010030
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WAERABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2011-10-20
- Decision date
- 2012-11-02
- Days to decision
- 379 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR SEVERAL HARDWARE DESIGN CHANGES AND A SOFTWARE DRIVER UPATE.
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