PMA P180036S025
- Device
- OPTIMIZER Smart Mini IPG
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S025
- Product code
- QFV
- Decision date
- 2024-02-09
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- approval for implantable pulse generator firmware version 1.11 to update the charging algorithm and bug fixes.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart Mini IPG
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S025
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2024-02-09
- Decision code
- APPR
- Date received
- 2023-12-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for implantable pulse generator firmware version 1.11 to update the charging algorithm and bug fixes.