PMA P080012S069
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S069
- Product code
- LKK
- Decision date
- 2021-03-02
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for a minor software changes to address three minor issues with the Patient Therapy controller REF 12860.
Current openFDA PMA Record#
- Device
- Prometra Programmable Infusion Pump System
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S069
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2021-03-02
- Decision code
- APPR
- Date received
- 2020-12-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a minor software changes to address three minor issues with the Patient Therapy controller REF 12860.