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: lntera 3000 Hepatic Artery Infusion Pump
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Intera Oncology; 180 Wells Ave., Suite 300a; Newton, MA 02459
• PMA Number: P890055
• Supplement Number: S079
• Date Received: 01/14/2022
• Decision Date: 01/27/2022
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change in the supplier of Can component of the Intera 3000 pump.