PMA P080012S037
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM CLINICIAN PROGRAMMER
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S037
- Product code
- LKK
- Decision date
- 2016-12-16
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for clinician programmer software update to add a print tool and implement software/firmware bug fixes.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM CLINICIAN PROGRAMMER
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S037
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2016-12-16
- Decision code
- APPR
- Date received
- 2016-09-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for clinician programmer software update to add a print tool and implement software/firmware bug fixes.