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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.
 
DeviceFACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantAbbott Vascular Devices
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP910031
Supplement NumberS010
Date Received07/23/1996
Decision Date12/02/1996
Reclassified Date10/08/2011
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODELS OF THE FACT(TM) AND ARC(TM) BALLOON CORONARY DILATATIN CATHETERS WITH AN ADD'L RADIOPAQUE MARKER
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