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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 NameQUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP860019
Supplement NumberS252
Date Received03/08/2010
Decision Date05/11/2010
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for material and specification changes to the strain relief.
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