FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implantable Pulse Generator
PMA: P180036
·
Supplement: S008
·
Decision Oct 6, 2021
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Implantable Pulse Generator
- Trade Name
- Optimizer Smart System and Optimizer Smart Mini System
- PMA Number
- P180036
- Supplement Number
- S008
- 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
- October 6, 2021
- Date Received
- June 24, 2021
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for removing the Indications For Use requirement for patients to be in normal sinus rhythm.
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 |