PMA P180036S021
- Device
- OPTIMIZER Smart Mini (OSM) system
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S021
- Product code
- QFV
- Decision date
- 2023-08-03
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval to add the OPTIMIZER Lite system version.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart Mini (OSM) system
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S021
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2023-08-03
- Decision code
- APPR
- Date received
- 2023-05-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add the OPTIMIZER Lite system version.