LIFE VEST, MODEL WCD 3000
FDA premarket approval P010030/S004 · decided 2003-09-02
Approval details
- PMA number
- P010030
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFE VEST, MODEL WCD 3000
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2003-07-18
- Decision date
- 2003-09-02
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR MINOR SOFTWARE, HARDWARE, AND LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST (WCD 3000) 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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