PMA P890055S061

Device: MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P890055
Supplement: S061
Product code: LKK
Decision date: 2015-10-08
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: CHANGES TO THE STERILIZATION PROCESS: 1) STEAM INJECTION RATE CURRENTLY AT 20 MBAR/MIN WILL CHANGE TO 5 MBAR/MIN; 2) GAS INJECTION RATE CURRENTLY AT 25 MBAR/MIN WILL CHANGE TO 20 MBAR/MIN; 3) MINIMUM PRIMARY DEGASSING TIME OF 10 HOURS WILL CHANGE TO 8 HOURS; 4) THE HANDLES FROM THE STERILIZATION SHIPPER, NUMBER 197548018, WILL BE REMOVED; 5) ADD A SECOND ETHYLENE OXIDE (EO) STERILIZATION CHAMBER (CHAMBER #4; 6) A MINIMUM EO STERILIZATION LOAD IN CHAMBER #3 (EXISTING CHAMBER) AND CHAMBER #4; AND 7) A 2X EO STERILIZATION FOR BOTH CHAMBER #3 AND #4.

Current openFDA PMA Record#

Device: MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P890055
Supplement: S061
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2015-10-08
Decision code: OK30
Date received: 2015-09-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE STERILIZATION PROCESS: 1) STEAM INJECTION RATE CURRENTLY AT 20 MBAR/MIN WILL CHANGE TO 5 MBAR/MIN; 2) GAS INJECTION RATE CURRENTLY AT 25 MBAR/MIN WILL CHANGE TO 20 MBAR/MIN; 3) MINIMUM PRIMARY DEGASSING TIME OF 10 HOURS WILL CHANGE TO 8 HOURS; 4) THE HANDLES FROM THE STERILIZATION SHIPPER, NUMBER 197548018, WILL BE REMOVED; 5) ADD A SECOND ETHYLENE OXIDE (EO) STERILIZATION CHAMBER (CHAMBER #4; 6) A MINIMUM EO STERILIZATION LOAD IN CHAMBER #3 (EXISTING CHAMBER) AND CHAMBER #4; AND 7) A 2X EO STERILIZATION FOR BOTH CHAMBER #3 AND #4.