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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 NumberS001
Date Received03/06/2012
Decision Date05/03/2012
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study protocol.
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