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Devices@FDA

 
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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 NameSIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheter
ApplicantADVANCED CATHETER SYSTEMS
PMA NumberP810046
Supplement NumberS036
Date Received07/31/1987
Decision Date10/06/1987
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
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