Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S040 · decided 2019-01-28
Approval details
- PMA number
- P080012
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Prometra Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2017-04-12
- Decision date
- 2019-01-28
- Days to decision
- 656 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for updates to the hardware (Clinician Programmer Model #13828), software and labeling of the Clinician Programmer and modifications to the software and labeling of the Patient Therapy Controller (PTC) for the Prometra Programmable Infusion Pump System.
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