PMA P080012S045
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S045
- Product code
- LKK
- Decision date
- 2017-08-21
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S045
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2017-08-21
- Decision code
- APPR
- Date received
- 2017-06-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for revised protocol for the post-approval study (PAS) protocol.