PMA P080012S051
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S051
- Product code
- LKK
- Decision date
- 2018-08-17
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for changes made to the dimensions of the Access Port Spacer part in the PROMETRA Programmable Infusion Pump System.
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S051
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2018-08-17
- Decision code
- APPR
- Date received
- 2018-05-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes made to the dimensions of the Access Port Spacer part in the PROMETRA Programmable Infusion Pump System.