PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA premarket approval P080012 · decided 2012-02-07
Approval details
- PMA number
- P080012
- Trade name
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2008-04-11
- Decision date
- 2012-02-07
- Days to decision
- 1397 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 INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION) OR PRESERVATIVE-FREE STERILE 0.9% SALINE SOLUTION (SODIUM CHLORIDE INJECTION, USP).
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