LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S020 · decided 2010-06-09
Approval details
- PMA number
- P010030
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2010-05-06
- Decision date
- 2010-06-09
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- MINOR TEST MODIFICATION TO AN ELECTRODE BELT FUNCTIONAL TEST.
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