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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 NameCROSS SAIL CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheter
Regulation Number870.5100
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP810046
Supplement NumberS202
Date Received10/16/2000
Decision Date11/03/2000
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 
Modifications as follows: 1) modify the troubleshooting process describing how to release the tubing form a mold; 2) modify the set-up/cleaning process prior to joining the device at the mod-lap joint; 3) modify the set-up process prior to plasma treating the device.
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