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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 NameNEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM
Classification Namestent, carotid
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP050025
Supplement NumberS003
Date Received04/12/2007
Decision Date05/10/2007
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an inspection procedure and a new visual standard that will be implemented as part of routine receiving and inspection for a subassembly used with the nexstent carotid stent system.
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