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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.
 
DeviceTHE ORACLE MEGASONICS FIVE-64 PTCA CATHER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantAbbott Vascular Devices
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP910031
Supplement NumberS019
Date Received06/15/1998
Decision Date12/11/1998
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 modifications to the Endosonics Oracle MegaSonics Five-64(TM) PTCA Catheter.
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