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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.
 
DeviceORACLE MEGASONICS FIVE-64 PTCA CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantAbbott Vascular Devices
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP910031
Supplement NumberS016
Date Received05/22/1997
Decision Date06/27/1997
Reclassified Date10/08/2011
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE 30 MM BALLOON LENGTH TO THE ARC(TM) BALLOON CORONARY DILATATION CATHETERS.
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