FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Wearable Automated External Defibrillator
PMA: P200037
·
Supplement: S010
·
Decision Oct 25, 2023
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Wearable Automated External Defibrillator
- Trade Name
- ASSURE Wearable Cardioverter Defibrillator System (ASSURE system)
- PMA Number
- P200037
- Supplement Number
- S010
- Device Class
- FDA Class 3
- Product Code
- MVK
- Generic Name
- Wearable automated external defibrillator
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 25, 2023
- Date Received
- September 28, 2023
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
the addition of a new contract manufacturer for a cable component
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 |