FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Wearable Automated External Defibrillator
PMA: P010030
·
Supplement: S004
·
Decision Sep 2, 2003
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Wearable Automated External Defibrillator
- Trade Name
- LIFE VEST, MODEL WCD 3000
- PMA Number
- P010030
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- MVK
- Generic Name
- Wearable automated external defibrillator
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 2, 2003
- Date Received
- July 18, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVK | Wearable Automated External Defibrillator | FDA class 3 | Unknown |