PMA P180036S034
- Device
- OPTIMIZER SMART Mini IPG
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S034
- Product code
- QFV
- Decision date
- 2025-11-19
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- a process change for epoxy headers of OPTIMIZER implantable pulse generators
Current openFDA PMA Record#
- Device
- OPTIMIZER SMART Mini IPG
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S034
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2025-11-19
- Decision code
- APPR
- Date received
- 2024-08-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a process change for epoxy headers of OPTIMIZER implantable pulse generators