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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 MONORAIL/OVER THE WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PICA) CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP860019
Supplement NumberS181
Date Received04/10/2002
Decision Date04/24/2002
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATE MANUFACTURING PROCESS TO PRODUCE BALLOONS FOR THE MAVERICK MONORAIL PTCA CATHETER AND THE MAVERICK OTW PTCA CATHETER. THE ALTERNATE PROCESS AFFECTS ONLY THE METHOD OF STRETCHING THE BALLOON TUBING PRIOR TO MOLDING THE BALLOON.
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