LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S025 · decided 2012-06-29
Approval details
- PMA number
- P010030
- Supplement
- S025
- 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
- 2011-01-03
- Decision date
- 2012-06-29
- Days to decision
- 543 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE LIFEVEST GARMENT INCLUDING LOCATION OF THE REAR THERAPY PADS AND VIBRATION BOX, METHOD OF SECURING VIBRATION BOX TO GARMENT, ADJUSTMENT MECHANISM FOR SHOULDER STRAP, WIDTH OF ELASTIC STRAP AND RELATED LABELING CHANGES.
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