PMA P180036S023
- Device
- OPTIMIZER® Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S023
- Product code
- QFV
- Decision date
- 2023-09-22
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for changes to the battery of the Smart Mini Charger.
Current openFDA PMA Record#
- Device
- OPTIMIZER® Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S023
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2023-09-22
- Decision code
- APPR
- Date received
- 2023-06-23
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the battery of the Smart Mini Charger.