FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
PMA: P030005
·
Supplement: S251
·
Decision Dec 17, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- Trade Name
- VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228)
- PMA Number
- P030005
- Supplement Number
- S251
- Device Class
- FDA Class 3
- Product Code
- NKE
- Generic Name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 17, 2025
- Date Received
- November 21, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to implement a new acceptance activity and associated equipment for extended life (EL) pacemaker and CRT-P batteries
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 |
|---|---|---|---|
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA class 3 | Unknown |