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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.
 
DeviceBX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY
Generic NameSTENT, CORONARY
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP900043
Supplement NumberS044
Date Received06/02/2003
Decision Date07/02/2003
Withdrawal Date09/02/2008
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT CORDIS DE MEXICO S.A. DE C.V., CHIHUAHUA, MEXICO.
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