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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.
 
DevicePTCA DILATATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP880003
Supplement NumberS093
Date Received11/02/2007
Decision Date11/30/2007
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).
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