LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S010 · decided 2008-04-17
Approval details
- PMA number
- P010030
- Supplement
- S010
- 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
- 2008-02-19
- Decision date
- 2008-04-17
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR A SOFTWARE CHANGE (VERSION 4.1) TO MAKE THE THERAPY ELECTRODE (TE) FALLOFF DETECTION MORE SPECIFIC.
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