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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 NameROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Classification Namecatheter, coronary, atherectomy
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS090
Date Received07/23/2007
Decision Date10/03/2007
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the directions for use for the rotablator rotational angioplasty system, guidewire with wireclip torquer.
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