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: Model 400 Implantable Infusion Pump
• Generic Name: pump, infusion, implanted, programmable
• Applicant: Intera Oncology; 65 william street; suite 2000; wellesley, MA 02481
• PMA Number: P800036
• Supplement Number: S040
• Date Received: 06/08/2017
• Decision Date: 07/05/2017
• Withdrawal Date: 03/12/2021
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Implementation of a new sterilization chamber control system at the sterilization facility to replace the current system.