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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.
 
DevicePALMAZ BALLON-EXPANABLE STENT
Generic NameSTENT, RENAL
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP890017
Supplement NumberS006
Date Received12/31/1998
Decision Date02/05/1999
Product Code NIN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
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 manufacturing site located at Cordis Corporation, 14201 N.W. 60th Ave., Miami Lakes, FL 33014.
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