Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S056 · decided 2020-12-30
Approval details
- PMA number
- P080012
- Supplement
- S056
- 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
- 2019-02-21
- Decision date
- 2020-12-30
- Days to decision
- 678 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Alternate electronics board manufacturer/supplier for the production of the Patient Therapy (PTC) Battery Charger and PTC Wand printed circuit boards.
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