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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.
Classification Namestent, renal
Generic Namestent, renal
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP060006
Supplement NumberS054
Date Received01/14/2014
Decision Date02/13/2014
Product Code
NIN[ Registered Establishments with NIN ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Equipment change to one of the ethylene oxide sterilization chambers.