Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S042 · decided 2017-07-21
Approval details
- PMA number
- P080012
- Supplement
- S042
- Supplement type
- Real-Time Process
- 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
- 2017-05-03
- Decision date
- 2017-07-21
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for electronic component changes occurring in the electronics module of the Flowonix Prometra Infusion Pump.
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