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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheters
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP860019
Supplement NumberS186
Date Received07/17/2002
Decision Date11/21/2002
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification of the laser welding process for the maverick otw, maverick monorail & maverick2 monorail ptca catheters.
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