PMA P180036S033
- Device
- OPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S033
- Product code
- QFV
- Decision date
- 2025-03-27
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- additional of a raw material supplier for epoxy resin used in the OPTIMIZER IPG devices.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S033
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2025-03-27
- Decision code
- APPR
- Date received
- 2024-08-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- additional of a raw material supplier for epoxy resin used in the OPTIMIZER IPG devices.