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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.
 
DeviceSIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 ynez rd.
temecula, CA 92591
PMA NumberP810046
Supplement NumberS015
Date Received08/01/1985
Decision Date03/06/1986
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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