PMA P180036
- Device
- OPTIMIZER Smart and Smart Mini
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S015
- Product code
- QFV
- Decision date
- 2026-05-13
- Generic name
- Implantable pulse generator
- Approval order statement
- an alternative vapor degreasing solvent used by a supplier
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart and Smart Mini
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S043
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2026-05-13
- Decision code
- OK30
- Date received
- 2026-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative vapor degreasing solvent used by a supplier