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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.
 
DeviceMERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantABBOTT VASCULAR DEVICES
400 SAGINAW DR.
REDWOOD CITY, CA 94063
PMA NumberP910031
Supplement NumberS022
Date Received11/01/2004
Decision Date02/16/2006
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 THE MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW). THE MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE NC MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
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