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: INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Intera Oncology; 65 William St.; Suite 2000; Wellesley, MA 02481
• PMA Number: P800036
• Supplement Number: S011
• Date Received: 09/20/1984
• Decision Date: 06/19/1986
• Withdrawal Date: 03/12/2021
• Product Code: LKK
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No