PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA premarket approval P080012/S019 · decided 2014-02-04
Approval details
- PMA number
- P080012
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2013-08-09
- Decision date
- 2014-02-04
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR THE ADDITION OF A CATHETER REVISION KIT FOR USE WITH THE SUBJECT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROMETRA PROGRAMMABLE IMPLANTABLE PUMP SYSTEM AND IS INDICATED FOR INTRATHECAL INFUSION OF INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE) OR PRESERVATIVE-FREE STERILE 0.9% SALINE SOLUTION (SODIUM CHLORIDE INJECTION, USP).
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