FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implantable Pulse Generator
PMA: P180036
·
Supplement: S034
·
Decision Nov 19, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Implantable Pulse Generator
- Trade Name
- OPTIMIZER SMART Mini IPG
- PMA Number
- P180036
- Supplement Number
- S034
- Device Class
- FDA Class 3
- Product Code
- QFV
- Generic Name
- Implantable pulse generator
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 19, 2025
- Date Received
- August 15, 2024
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a process change for epoxy headers of OPTIMIZER implantable pulse generators
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 |
|---|---|---|---|
| QFV | Implantable Pulse Generator | FDA class 3 | Unknown |