Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: INFUSAID 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
• Date Received: 06/23/1980
• Decision Date: 03/03/1982
• Withdrawal Date: 03/12/2021
• Product Code: LKK
• Docket Number: 82M-0072
• Notice Date: 03/26/1982
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 ; S013 S015 S016 S018 S019 S021 S024 S025 S029 S030 S031 S032 ; S034 S035 S036 S037 S038 S039 S040 S041