PMA P080012S060
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S060
- Product code
- LKK
- Decision date
- 2019-09-23
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for introducing Software Version 2.01.5 for the Prometra Clinician Programmer, Cat. Nos. 12828 and 13828, used with Prometra and Prometra II Programmable Pumps and minor labeling changes to explain reduced functionality accompanying this revision.
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S060
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2019-09-23
- Decision code
- APPR
- Date received
- 2019-07-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for introducing Software Version 2.01.5 for the Prometra Clinician Programmer, Cat. Nos. 12828 and 13828, used with Prometra and Prometra II Programmable Pumps and minor labeling changes to explain reduced functionality accompanying this revision.