Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S072 · decided 2022-04-28
Approval details
- PMA number
- P080012
- Supplement
- S072
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Prometra Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2022-03-30
- Decision date
- 2022-04-28
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for labeling updates to the refill kit and MRI scan instructions for use.
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