PMA P180036S022
- Device
- OPTIMIZER® Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S022
- Product code
- QFV
- Decision date
- 2023-09-18
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for changes to the printed circuit board (PCB), including the location of the thermistor component.
Current openFDA PMA Record#
- Device
- OPTIMIZER® Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S022
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2023-09-18
- Decision code
- APPR
- Date received
- 2023-05-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the printed circuit board (PCB), including the location of the thermistor component.