PMA P180036S011
- Device
- OPTIMIZER Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S011
- Product code
- QFV
- Decision date
- 2021-12-16
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for software changes to the Optimizer Smart Mini firmware.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S011
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2021-12-16
- Decision code
- APPR
- Date received
- 2021-09-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes to the Optimizer Smart Mini firmware.