LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S032 · decided 2012-07-13
Approval details
- PMA number
- P010030
- Supplement
- S032
- 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
- 2012-05-14
- Decision date
- 2012-07-13
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR 2 MECHANICAL DESIGN MODIFICATIONS TO THE METHOD OF ATTACHING THE HOOK COMPONENT OF THE HOOK AND LOOP FASTENERS TO THE ECG ELECTRODE HOUSING.
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