FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implantable Pulse Generator
PMA: P180036
·
Supplement: S013
·
Decision Dec 2, 2022
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Implantable Pulse Generator
- Trade Name
- OPTIMIZER SMART MINI, INTELIO Programmer, OPTIhome Remote Patient Monitoring System, Universal GUARDIO
- PMA Number
- P180036
- Supplement Number
- S013
- 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
- December 2, 2022
- Date Received
- April 6, 2022
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for changes made to the GUARDIO Charger as well as other related changes to device components to accommodate its use with the OPTIhome system.
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 |