LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S052 · decided 2015-04-09
Approval details
- PMA number
- P010030
- Supplement
- S052
- 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
- 2014-05-21
- Decision date
- 2015-04-09
- Days to decision
- 323 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE PRINTED CIRCUIT BOARD (PCB) INTHE LIFEVEST 4000 BATTERY PACK TO ACCOMMODATE AN END-OF-LIFE REPLACEMENT PROTECTOR CIRCUIT IC.
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