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: PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Algorithm Sciences, Inc.; 121 Shelley Drive; 2H; Hackettstown, NJ 07840
• PMA Number: P080012
• Date Received: 04/11/2008
• Decision Date: 02/07/2012
• Product Code: LKK
• Docket Number: 12M-0180
• Notice Date: 02/27/2012
• Advisory Committee: General Hospital
• Clinical Trials: NCT00817596
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM. THE DEVICE IS INDICATED FOR INTRATHECAL INFUSION OF INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION) OR PRESERVATIVE-FREE STERILE 0.9% SALINE SOLUTION (SODIUM CHLORIDE INJECTION, USP).

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S006 S007 S009 S010 S011 S012 S013 ; S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S028 ; S029 S030 S031 S032 S033 S035 S036 S037 S039 S040 S041 S042 ; S043 S044 S045 S046 S047 S049 S050 S051 S053 S055 S056 S057 ; S058 S059 S060 S061 S062 S063 S064 S065 S067 S068 S069 S070 ; S072