PMA P080012S053
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S053
- Product code
- LKK
- Decision date
- 2018-12-17
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Adding a laser welding operation at the pump contract manufacturer.
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S053
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2018-12-17
- Decision code
- OK30
- Date received
- 2018-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding a laser welding operation at the pump contract manufacturer.