PMA P180036S026
- Device
- OPTIMIZER® Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S026
- Product code
- QFV
- Decision date
- 2024-01-03
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- to add a refurbishment process for the Mini Charger by replacing the battery pack
Current openFDA PMA Record#
- Device
- OPTIMIZER® Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S026
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2024-01-03
- Decision code
- OK30
- Date received
- 2023-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a refurbishment process for the Mini Charger by replacing the battery pack