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: MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Intera Oncology; 180 Wells Ave., Suite 300a; Newton, MA 02459
• PMA Number: P890055
• Date Received: 09/28/1989
• Decision Date: 03/11/1996
• Product Code: LKK
• Docket Number: 96M-0239
• Notice Date: 07/16/1996
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP

• Supplements: S003 S026 S013 S020 S021 S014 S039 S011 S018 S016 S017 ; S025 S034 S043 S012 S047 S059 S049 S008 S009 S052 S053 S055 ; S056 S057 S027 S028 S029 S030 S031 S032 S033 S001 S002 S065 ; S004 S005 S006 S035 S060 S045 S046 S058 S050 S051 S038 S048 ; S040 S041 S071 S007 S010 S015 S061 S023 S024 S019 S063 S066 ; S067 S062 S064 S068 S069 S074 S077 S080 S081 S085 S070 S073 ; S075 S076 S072 S083 S079 S082 S078 S086 S087 S084 S088 S089 ; S090