PMA P080012S032

Device: PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S032
Product code: LKK
Decision date: 2015-11-24
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: TO MODIFY THE MANUFACTURING PROCEDURE FOR THE PATIENT THERAPY CONTROLLER (PTC) TO REROUTE THE PTC'S POWER CABLE WITHIN THE ASSEMBLY TO PREVENT IT FROM DAMAGE. ADDITIONALLY, UPDATE THE FINAL RELEASE TEST TO ADD A "BOLUS TEST" TO FURTHER VERIFY THE OPERATION OF THE PTC PRIOR TO RELEASE.

Current openFDA PMA Record#

Device: PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
Applicant: Infusyn Therapeutics, LLC
PMA number: P080012
Supplement: S032
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2015-11-24
Decision code: OK30
Date received: 2015-10-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: TO MODIFY THE MANUFACTURING PROCEDURE FOR THE PATIENT THERAPY CONTROLLER (PTC) TO REROUTE THE PTC'S POWER CABLE WITHIN THE ASSEMBLY TO PREVENT IT FROM DAMAGE. ADDITIONALLY, UPDATE THE FINAL RELEASE TEST TO ADD A "BOLUS TEST" TO FURTHER VERIFY THE OPERATION OF THE PTC PRIOR TO RELEASE.