FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Implantable Cardioverter Defibrillator (Non-Crt)
PMA: P980016
·
Supplement: S941
·
Decision Dec 3, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Implantable Cardioverter Defibrillator (Non-Crt)
- Trade Name
- Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ
- PMA Number
- P980016
- Supplement Number
- S941
- Device Class
- FDA Class 3
- Product Code
- LWS
- Generic Name
- Implantable cardioverter defibrillator (non-CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 3, 2025
- Date Received
- November 7, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an update to the substrate defect mapping process
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 |
|---|---|---|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | FDA class 3 | Unknown |