LIFEVEST WEARABLE DEFIBRILLATOR
FDA premarket approval P010030/S056 · decided 2015-12-17
Approval details
- PMA number
- P010030
- Supplement
- S056
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFEVEST WEARABLE DEFIBRILLATOR
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2013-02-19
- Decision date
- 2015-12-17
- Days to decision
- 1031 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR THE LIFEVEST WEARABLE CARDIOVERTER DEFIBRILLATOR, MODELS 3000, 3100, AND 4000. THE LIFEVEST SYSTEM IS INDICATED FOR PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. THE LIFEVEST SYSTEM ISINDICATED FOR PATIENTS UNDER 18 YEARS OF AGE WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. PATIENTS MUST HAVE A CHEST CIRCUMFERENCE OF 26 INCH
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