Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28
FDA premarket approval P080012/S062 · decided 2019-10-22
Approval details
- PMA number
- P080012
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2019-08-16
- Decision date
- 2019-10-22
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for introducing Software Version 0.28 for the Prometra II Pumps (REF 13827, 20 mL Pump and Ref 16827, 40 mL Pump).
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