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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceWALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BOSTON SCIENTIFIC CORPORATION
one scimed place
maple grove, MN 55311-1566
PMA NumberP980033
Supplement NumberS006
Date Received03/12/2003
Decision Date04/01/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) MANUAL, NAMELY A MODIFICATION TO THE SIZING REQUIREMENTS OF THE INTRODUCER SHEATHS AND A MODIFICATION TO THE DESCRIPTION OF THE RECOMMENDED GUIDE WIRE TO BE USED WITH THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM.
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