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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 postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study protocol.
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