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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP900056
Supplement NumberS084
Date Received04/25/2005
Decision Date05/25/2005
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL QUALITY CONTROL (QC) INSPECTION METHOD USING THE PASSAGE OF GUIDEWIRE THROUGH THE ROTALINK PLUS DEVICE LUMEN TO VERIFY THE DEVICE IS FREE FROM OBSTRUCTIONS.
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