PMA P080012S021

Device: PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S021
Product code: LKK
Decision date: 2015-02-10
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR A NEW PROGRAMMER DEVICE. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PROMETRA PROGRAMMABLE INFUSION 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).

Current openFDA PMA Record#

Device: PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S021
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2015-02-10
Decision code: APPR
Date received: 2014-04-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW PROGRAMMER DEVICE. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PROMETRA PROGRAMMABLE INFUSION 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).