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: MEDTRONIC ISOMED INFUSION SYSTEM
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Medtronic, Inc.; 7000 Central Ave., NE; Minneapolis, MN 55432
• PMA Number: P990034
• Date Received: 06/28/1999
• Decision Date: 07/21/2000
• Product Code: LKK
• Docket Number: 00M-1495
• Notice Date: 09/21/2000
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE MEDTRONIC(R) ISOMED(R) CONSTANT FLOW INFUSION SYSTEM. THIS DEVICE IS INDICATED FOR USE WHEN PATIENT THERAPY REQUIRES THE CHRONIC INFUSION OF APPROVED DRUGS OR FLUIDS.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S022 S023 S024 S031 S032 S029 S013 S003 S005 S019 S011 ; S004 S006 S010 S001 S002 S035 S036 S025 S026 S033 S021 S016 ; S020 S012 S017 S018 S014 S015 S042 S041 S045 S038 S039 S044 ; S043