Prometra Programmable Infusion Pump System
FDA premarket approval P080012/S068 · decided 2022-01-12
Approval details
- PMA number
- P080012
- Supplement
- S068
- Supplement type
- Panel 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
- 2020-11-05
- Decision date
- 2022-01-12
- Days to decision
- 433 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- Approval for the Prometra® Programmable Infusion Pump System. The device is indicated for intrathecal infusion of drug therapy, including: Infumorph ® (preservative free morphine sulfate sterile solution), preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP), and baclofen (baclofen injection, intrathecal, 500-2000 mcg/mL). For Infumorph, the pump system is indicated for use in patient populations of 22 years and older (adults). For baclofen, the pump system is indicate
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