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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 NameACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS196
Date Received12/22/1998
Decision Date01/22/1999
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the implementation of an additional quality control inspection to further ensure that hte balloon size designation on the proximal adaptor is correct fo rthe acs rx comet vp(tm) coronary dilatation catheter and the other acs coronary dilatation catheters listed in the supplement.
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