PMA P890055S065

Device: CODMAN 3000 CONSTANT-FLOW IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P890055
Supplement: S065
Product code: LKK
Decision date: 2016-09-26
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Use a suture material for the Codman 3000 Implantable Infusion Pump from a supplier that has changed ownership from Sherwood Davis & Geck to Medtronic.

Current openFDA PMA Record#

Device: CODMAN 3000 CONSTANT-FLOW IMPLANTABLE INFUSION PUMP
Applicant: Intera Oncology
PMA number: P890055
Supplement: S065
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2016-09-26
Decision code: OK30
Date received: 2016-08-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Use a suture material for the Codman 3000 Implantable Infusion Pump from a supplier that has changed ownership from Sherwood Davis & Geck to Medtronic.