LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S059 · decided 2015-11-06
Approval details
- PMA number
- P010030
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2014-12-22
- Decision date
- 2015-11-06
- Days to decision
- 319 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR:1) REDESIGNED ECG AND BELT NODE PCAS; 2) ADDITION OF A FERRITE BEAD TO THE TRUNK CABLE ASSEMBLY AND MODIFICATION TO THE BELT NODE PLASTIC ENCLOSURE; 3) CONNECTORIZED THERAPY ELECTRODE (TE); 4) THERAPY ELECTRODE GAS GENERATOR PLASTIC ENCLOSURE INSPECTION WINDOW; 5) ADDITION OF AN ACCELEROMETER TO THE FRONT TE AND ADDITIONAL CONDUCTORS TO THE CABLE ASSEMBLIES6) ADDITION OF THE TE ADVISORY LABELS TO THE ELECTRODE BELT.
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