LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000)
FDA premarket approval P010030/S011 · decided 2009-08-17
Approval details
- PMA number
- P010030
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000)
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2008-09-05
- Decision date
- 2009-08-17
- Days to decision
- 346 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR THE NEXT GENERATION OF WEARABLE DEFIBRILLATORS DESIGNED TO BE SMALLER, LIGHTER, AND MORE USER-FRIENDLY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
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