PMA P890055S060

Device: CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C
Applicant: Intera Oncology
PMA number: P890055
Supplement: S060
Product code: LKK
Decision date: 2015-07-23
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: CHANGE IN THE VENDOR SUPPLIER THAT SUPPLIES THE TUBING FOR THE MEDSTREAM REFILL KIT AND MEDSTREAM BOLUS KIT AND A CHANGE IN THE FACILITY FOR MANUFACTURING OPERATIONS WITHIN THE SAME CAMPUS FOR THE VENDOR SUPPLIER THAT SUPPLIES THE TYVEK PACKAGING LIDS FOR THE CODMAN 3000 PUMP AND THE TYVEK RULERS FOR THE CODMAN INTRASPINAL CATHETER KITS.

Current openFDA PMA Record#

Device: CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C
Applicant: Intera Oncology
PMA number: P890055
Supplement: S060
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2015-07-23
Decision code: OK30
Date received: 2015-06-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE VENDOR SUPPLIER THAT SUPPLIES THE TUBING FOR THE MEDSTREAM REFILL KIT AND MEDSTREAM BOLUS KIT AND A CHANGE IN THE FACILITY FOR MANUFACTURING OPERATIONS WITHIN THE SAME CAMPUS FOR THE VENDOR SUPPLIER THAT SUPPLIES THE TYVEK PACKAGING LIDS FOR THE CODMAN 3000 PUMP AND THE TYVEK RULERS FOR THE CODMAN INTRASPINAL CATHETER KITS.