- Device
- Prometra II Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S057
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2020-01-15
- Decision code
- APPR
- Date received
- 2019-03-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for change in the sourcing of the lubricant chemical and in the resin tint blends to not include a carrier for two syringes and a stop cock which are components in the Prometra II® Programmable Infusion Pump Accessories the Refill Kit and the Catheter Access Port Kit.