PMA P180036S007
- Device
- OPTIMIZER Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S007
- Product code
- QFV
- Decision date
- 2021-07-30
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for commercial distribution of the OPTIMIZER SMART Mini System.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S007
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2021-07-30
- Decision code
- APPR
- Date received
- 2020-09-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for commercial distribution of the OPTIMIZER SMART Mini System.