PMA P080012S019

Device: PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S019
Product code: LKK
Decision date: 2014-02-04
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order 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).

Current openFDA PMA Record#

Device: PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S019
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2014-02-04
Decision code: APPR
Date received: 2013-08-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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).