Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Codman 3000 Series Constant Flow Implantable infusion Pump
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Intera Oncology; 180 Wells Ave., Suite 300a; Newton, MA 02459
• PMA Number: P890055
• Supplement Number: S069
• Date Received: 08/21/2017
• Decision Date: 07/06/2018
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a updated MRI labeling for the Codman 3000 pump.