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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
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantScimed Life Systems, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP860019
Supplement NumberS170
Date Received03/13/2001
Decision Date04/05/2001
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES IN THE MANUFACTURING PROCESS FOR THE MAVERICK MONORAIL PRODUCT LINE TO INCLUDE THE USE OF A NON-TAPERED PRODUCTION MANDREL WITH BLUNT ENDS, AND ADDITIONAL PREVENTIVE MEASURES TO ENSURE THAT A THIN WALL CONDITION DOES NOT OCCUR IN THE INFLATION LUMEN, ICLUDING THE ADDITION OF A 100% VACUUM DECAY TEST FOR BOTH THE MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS.
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