PMA P080012S072
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S072
- Product code
- LKK
- Decision date
- 2022-04-28
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for labeling updates to the refill kit and MRI scan instructions for use.
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S072
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2022-04-28
- Decision code
- APPR
- Date received
- 2022-03-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates to the refill kit and MRI scan instructions for use.