Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S063 · decided 2021-11-12
Approval details
- PMA number
- P080012
- Supplement
- S063
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Prometra Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2019-10-31
- Decision date
- 2021-11-12
- Days to decision
- 743 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for a manufacturing equipment change and raw material change used to manufacture a subcomponent of the Prometra Programmable Infusion Pump System.
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