PMA P080012S059
- Device
- Prometra II Programmable Infusuin Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S059
- Product code
- LKK
- Decision date
- 2019-08-07
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Alternate supplier for the bellows component of the Prometra II Programmable Infusion Pump System.
Current openFDA PMA Record#
- Device
- Prometra II Programmable Infusuin Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S059
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2019-08-07
- Decision code
- OK30
- Date received
- 2019-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the bellows component of the Prometra II Programmable Infusion Pump System.