FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Wearable Automated External Defibrillator
PMA: P010030
·
Supplement: S073
·
Decision Jun 14, 2016
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Wearable Automated External Defibrillator
- Trade Name
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- PMA Number
- P010030
- Supplement Number
- S073
- 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
- June 14, 2016
- Date Received
- March 16, 2016
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for modifications to current software (bug fixes, improvements, background noise detection feature).
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 |