• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Applicant
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mt.olive, NJ 07828
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 Trials NCT00817596
Expedited Review Granted? No
Combination Product No
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:  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 S069 
-
-