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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 NameEXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Classification Namestent, renal
ApplicantBOSTON SCIENTIFIC
PMA NumberP060006
Supplement NumberS023
Date Received11/14/2011
Decision Date12/13/2011
Product Code
NIN[ Registered Establishments with NIN ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the heat shrink processing aid used to deliver heat shrink force for the proximal bond of the catheter.
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