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: S034 S028 S029 S030 S031 S032 S033 S003 S004 S005 S006 S001 ; S002 S055 S056 S007 S049 S050 S051 S035 S040 S041 S043 ; S019 S012 S015 S010 S020 S021 S018 S016 S017 S008 S009 S023 ; S024 S014 S062 S066 S063 S064 S011 S039 S045 S046 S058 S060 ; S057 S047 S059 S061 S052 S048 S027 S013 S026 S025 S065 S067 ; S068 S071 S069 S070 S076 S082 S080 S081 S078 S092 S073 S074 ; S075 S072 S077 S083 S079 S084 S085 S086 S087 S088 S089 S090 ; S093 S053 S038