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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 PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP880003
Supplement NumberS059
Date Received04/29/1996
Decision Date06/05/1996
Reclassified Date10/08/2010
Product Code 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 A MODIFIED BALLOON FOLDING MACHINE
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