PMA P180036S028
- Device
- OPTIMIZER® Smart Mini
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S028
- Product code
- QFV
- Decision date
- 2024-06-13
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- modifications to the current 1.1.4.3 OPTIMIZER® Smart Mini implantable pulse generator (IPG) Application Software used by the INTELIO Programmer
Current openFDA PMA Record#
- Device
- OPTIMIZER® Smart Mini
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S028
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2024-06-13
- Decision code
- APPR
- Date received
- 2024-03-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- modifications to the current 1.1.4.3 OPTIMIZER® Smart Mini implantable pulse generator (IPG) Application Software used by the INTELIO Programmer