FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implantable Pulse Generator
PMA: P180036
·
Supplement: S002
·
Decision Aug 13, 2019
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Implantable Pulse Generator
- Trade Name
- OPTIMIZER Smart System
- PMA Number
- P180036
- Supplement Number
- S002
- 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
- August 13, 2019
- Date Received
- June 21, 2019
- Supplement Type
- Real-Time Process
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for changes to the circuit components of the OPTIMIZER Smart IPG to improve manufacturability, robustness, and reliability.
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 |