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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 NumberS013
Date Received05/17/2010
Decision Date10/04/2010
Product Code
NIN[ Registered Establishments with NIN ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate stent finishing process using an automated system in place of the current manual system.
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