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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.
 
DeviceMAVERICK 2 MONORAIL PTCA CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantScimed Life Systems, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP860019
Supplement NumberS179
Date Received02/07/2002
Decision Date11/20/2002
Reclassified Date10/08/2010
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 THE MAVERICK2 MONORAIL PTCA CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAVERICK2 MONORAIL PTCA CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE MAVERICK2 BALLOON CATHETER (2.25 - 4.00 MM) IS ALSO INDICATED FOR THE POST DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
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