PMA P180036S029
- Device
- OPTIMIZER® Smart Mini
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S029
- Product code
- QFV
- Decision date
- 2024-08-13
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- approval for version 1.12 of the OPTIMIZER Smart Mini IPG firmware
Current openFDA PMA Record#
- Device
- OPTIMIZER® Smart Mini
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S029
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2024-08-13
- Decision code
- APPR
- Date received
- 2024-05-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for version 1.12 of the OPTIMIZER Smart Mini IPG firmware