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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 NameNC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP860019
Supplement NumberS241
Date Received09/04/2009
Decision Date04/16/2010
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) a new balloon and markerband materials; 2) extension of the product matrix to include a 6mm length; 3) an alternate bond for monorail models; and 4) a change in the hydrophilic coating length on over-the-wire models.
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