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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS019
Date Received08/09/2013
Decision Date02/04/2014
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a catheter revision kit for use with the subject system. The device, as modified, will be marketed under the trade name prometra programmable implantable pump system and is indicated for intrathecal infusion of infumorph (preservative-free morphine sulfate) or preservative-free sterile 0. 9% saline solution (sodium chloride injection, usp).
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