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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.
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter, coronary, atherectomy
Boston Scientific Corp.
two scimed place
maple grove, MN 55311-1566
PMA NumberP900056
Supplement NumberS027
Date Received05/20/1999
Decision Date06/16/1999
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change for the rotablator system.