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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.
 
DeviceHIGHSAIL CORONARY DILATATION CATHETERS
Classification Namecatheter, flow directed
Generic Namecatheter, flow directed
Regulation Number870.1240
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 ynez rd.
temecula, CA 92591
PMA NumberP810046
Supplement NumberS212
Date Received03/11/2002
Decision Date05/10/2002
Product Code
DYG[ Registered Establishments with DYG ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the packaging by eliminating the flushing tool and replacing the dispenser tubing coil.
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