PMA P080012S062
- Device
- Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S062
- Product code
- LKK
- Decision date
- 2019-10-22
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for introducing Software Version 0.28 for the Prometra II Pumps (REF 13827, 20 mL Pump and Ref 16827, 40 mL Pump).
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S062
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2019-10-22
- Decision code
- APPR
- Date received
- 2019-08-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for introducing Software Version 0.28 for the Prometra II Pumps (REF 13827, 20 mL Pump and Ref 16827, 40 mL Pump).