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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 CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheter
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
PMA NumberP810046
Supplement NumberS167
Date Received07/09/1996
Decision Date01/08/1997
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
Combination Product No
Approval Order Statement 
Approval for the acs concorde(tm) coronary dilatation catheter with quarter size diameters in the 30 mm and 40 mm balloon lengths, a change in the proximal catheter marking material and changes tot he manufacturing process.
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