PMA P080012S074
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S074
- Product code
- LKK
- Decision date
- 2024-12-12
- Classification
- General Hospital
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- add a new Clinician Programmer
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S074
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2024-12-12
- Decision code
- APPR
- Date received
- 2024-09-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- add a new Clinician Programmer