PMA P080012S065
- Device
- Prometra II Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S065
- Product code
- LKK
- Decision date
- 2020-03-17
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Increasing the sterilization load size of Ethylene Oxide sterilized accessories of the Prometra Pump System.
Current openFDA PMA Record#
- Device
- Prometra II Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S065
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2020-03-17
- Decision code
- OK30
- Date received
- 2020-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increasing the sterilization load size of Ethylene Oxide sterilized accessories of the Prometra Pump System.