PMA P180036S017
- Device
- OPTIMZER Smart Mini IPG Firmware
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S017
- Product code
- QFV
- Decision date
- 2023-06-06
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for modifications of the Optimizer Smart Mini firmware.
Current openFDA PMA Record#
- Device
- OPTIMZER Smart Mini IPG Firmware
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S017
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2023-06-06
- Decision code
- APPR
- Date received
- 2023-03-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications of the Optimizer Smart Mini firmware.