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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 NamePERCUTANEOUS TRANSPLUMINAL CORONARY ANGIOPLASTY CATHETERS MAVERICK2 MONORAIL PTCA CATHETERS AND NC MONORAIL PTCA CATHETE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty (ptca) catheters
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP860019
Supplement NumberS207
Date Received02/02/2006
Decision Date03/02/2006
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 
Modification of the equipment nozzle to the mold used for making the manifold of the above-stated devices.
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