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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 IMPLANTABLE PUMP, 1031200
Classification Namepump, infusion, implanted, programmable
ApplicantFLOWONIX MEDICAL, INC.
PMA NumberP080012
Supplement NumberS009
Date Received10/10/2012
Decision Date11/06/2012
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of an alternate solder paste during the manufacture of the device.
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