PMA P180036S037
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S037
- Product code
- QFV
- Decision date
- 2025-03-18
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- approval for implantable pulse generator firmware version 1.16.0 to implement bug fixes and additional improvements
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S037
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2025-03-18
- Decision code
- APPR
- Date received
- 2024-12-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for implantable pulse generator firmware version 1.16.0 to implement bug fixes and additional improvements