LIFEVEST WEARABLE BEFIBRILLATOR
FDA premarket approval P010030/S028 · decided 2011-07-07
Approval details
- PMA number
- P010030
- Supplement
- S028
- Trade name
- LIFEVEST WEARABLE BEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2011-05-10
- Decision date
- 2011-07-07
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR USE OF THE E-ONE MOLI ENERGY 1HR18650B (2.25AH) LITHIUM-ION BATTERY CELL WITH YOUR LIFEVEST MODEL 4000 WEARABLE DEFIBRILLATOR.
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