LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S026 · decided 2011-03-28
Approval details
- PMA number
- P010030
- Supplement
- S026
- 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
- 2011-02-24
- Decision date
- 2011-03-28
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- ADDITION OF A NEW THERMOFORMING MACHINE.
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