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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 NameENDOTEX NEXSTENT CAROTID STENT AND MONORAIL
Classification Namestent, carotid
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP050025
Supplement NumberS002
Date Received03/07/2007
Decision Date04/10/2007
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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