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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.
 
DeviceRAPTORAIL PTCA DILATATION CATHETER (RX)
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP880003
Supplement NumberS083
Date Received02/01/2002
Decision Date02/12/2002
Reclassified Date10/08/2010
Product Codes LIT LOX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE QUALITY PLAN: 1) THE ADDITION OF A 100% VISUAL MARKER BAND PLACEMENT VERIFICATION; 2) THE ADDITION OF A QC AUDIT FOR MARKER BAND PLACEMENT VERIFICATION; AND 3) THE ADDITION OF A QC FUNCTIONAL TEST FOR INFLATION/DEFLATION TIME VERIFICATION.
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