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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheter
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
PMA NumberP810046
Date Received09/11/1981
Decision Date03/03/1982
Reclassified Date 10/08/2010
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 82M-0071
Notice Date 03/26/1982
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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