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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 CITY, CA 94063
PMA NumberP910031
Supplement NumberS015
Date Received03/28/1997
Decision Date05/01/1998
Reclassified Date 10/08/2011
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for Oracle MegaSonics Five-64(TM) PTCA Catheter. The device, as modified, will be marketed under the trade name Oracle MegaSonics Five-64(TM) PTCA Catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion. The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) dimensional measurements from the image.
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