- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S056
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2020-12-30
- Decision code
- APPR
- Date received
- 2019-02-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate electronics board manufacturer/supplier for the production of the Patient Therapy (PTC) Battery Charger and PTC Wand printed circuit boards.