LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S064 · decided 2015-11-06
Approval details
- PMA number
- P010030
- Supplement
- S064
- 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
- 2015-07-02
- Decision date
- 2015-11-06
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR TWO ELECTRICAL DESIGN CHANGES FOR THE LIFEVEST WEARABLEDEFIBRILLATOR 4000 MONITOR PULSE DELIVERY CIRCUITRY. THESE CHANGES INCLUDE AND INCREASE THE VALUES OF FOUR DC BLOCKING CAPACITORS ON THE DEFIBRILLATOR PCA AND TWO BULK CAPACITORS ON THE MONITOR COMPUTER/ANALOG (C/A) BOARD, AS WELL AS CHANGE THE DC BLOCKING CAPACITOR DIELECTRIC FROM Y5V TO X7R AND THE ADDITION OF FERRITE BEAD TO THE BATTERY POWER WIRE ON THE C/A BOARD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAM
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