FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Implantable Cardioverter Defibrillator (Non-Crt)
PMA: P980016
·
Supplement: S953
·
Decision Mar 6, 2026
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; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR I CD; Ev
- PMA Number
- P980016
- Supplement Number
- S953
- 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
- March 6, 2026
- Date Received
- February 6, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to replace the Novec 72DA solvent with the PWR-4 3910 solvent during the component cleaning 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 |