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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 NameBOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
Classification Namestent, carotid
Generic Namestent,carotid
ApplicantBOSTON SCIENTIFIC
PMA NumberP050019
Supplement NumberS004
Date Received02/01/2010
Decision Date07/28/2010
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for replacing the partially encapsulated radiopaque markerband on the distal end of the retractable outer sheath in the stent delivery system with a fully encapsulated radiopaque markerband.
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