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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 MONORAIL
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP860019
Supplement NumberS170
Date Received03/13/2001
Decision Date04/05/2001
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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