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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DevicePROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantInfusyn Therapeutics, LLC
121 Shelley Dr.
2h
Hackettstown, NJ 07840
PMA NumberP080012
Date Received04/11/2008
Decision Date02/07/2012
Product Code LKK 
Docket Number 12M-0180
Notice Date 02/27/2012
Advisory Committee General Hospital
Clinical TrialsNCT00817596
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S065 S058 S010 S011 S012 S035 S036 S037 S039 S013 S045 
S046 S040 S041 S042 S043 S044 S055 S056 S057 S067 S069 S075 
S073 S074 S051 S049 S047 S050 S059 S060 S061 S062 S064 S068 
S053 S063 S072 S070 S006 S007 S023 S032 S025 S022 S004 S018 
S009 S024 S030 S031 S028 S029 S016 S017 S014 S020 S021 S019 
S001 S002 S003 S033 
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