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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.
 
DeviceCORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM
Generic NameStent, carotid
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP030047
Supplement NumberS011
Date Received02/05/2008
Decision Date09/30/2008
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REDUCING THE SAMPLE SIZE FOR THE FOLLOWING PROCESSES: 1) THE FUSING OPERATION FOR ALL PRECISE DEVICES AND THE SEALING OPERATION FOR PRECISE RX; AND 2) THE BONDING PROCESS OF THE PRECISE RX AND PRECISE PRO RX SUPPORT MEMBER/WIRE LUMEN SUBASSEMBLY.
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