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: NFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Intera Oncology; 65 William Street; Suite 2000; Wellesley, MA 02481
• PMA Number: P800036
• Supplement Number: S021
• Date Received: 06/12/1989
• Decision Date: 10/18/1989
• Withdrawal Date: 03/12/2021
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No