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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.
 
DeviceCATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantABBOTT VASCULAR DEVICES
400 SAGINAW DR.
REDWOOD CITY, CA 94063
PMA NumberP910031
Supplement NumberS007
Date Received01/26/1996
Decision Date05/30/1996
Reclassified Date 10/08/2011
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR: 1)AN ADDITIONAL MANUFACTURING SITE (13900 ALTON PARKWAY, SUITE 122, IRVINE, CA, 92718); 2) AN ALTERNATE STERILIZATION SITE (GRIFFITH MICRO SCIENCE, 4900 GIFFORD AVE., LOS ANGELES, CA, 90058); AND 3) AN INCREASE IN THE SHELF LIFE FROM ONE TO TWO YEARS
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