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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.
 
Trade NamePROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Classification Namepump, infusion, implanted, programmable
ApplicantFLOWONIX MEDICAL, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S007 
S009 S010 S011 S014 
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