PMA P890055S062

Device: CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP.
Applicant: Intera Oncology
PMA number: P890055
Supplement: S062
Product code: LKK
Decision date: 2016-05-27
Classification: Pump, Infusion, Implanted, Programmable
Generic name: Pump, infusion, implanted, programmable
Approval order statement: Change for a new packaging equipment to seal the pouches for the Codman 3000 Constant-Flow Implantable Infusion Pump O.R. Prep Kit Tubing Assembly. External supplier, Command Medical Products (Command), has requested implementation of new packaging sealing equipment, a Sencorp bar sealer (12-PL/2) with a removable work surface. The supplier has requested the change as a process improvement.

Current openFDA PMA Record#

Device: CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP.
Applicant: Intera Oncology
PMA number: P890055
Supplement: S062
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2016-05-27
Decision code: OK30
Date received: 2016-04-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change for a new packaging equipment to seal the pouches for the Codman 3000 Constant-Flow Implantable Infusion Pump O.R. Prep Kit Tubing Assembly. External supplier, Command Medical Products (Command), has requested implementation of new packaging sealing equipment, a Sencorp bar sealer (12-PL/2) with a removable work surface. The supplier has requested the change as a process improvement.