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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DevicePROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Classification Namepump, infusion, implanted, programmable
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[ Registered Establishments with LKK ]
Docket Number 12M-0180
Notice Date 02/27/2012
Advisory Committee General Hospital
Clinical Trials NCT00817596
NCT00866164
Expedited Review Granted? No
Combination Product No
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 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 
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