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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 or ROTAPRO Rotational Atherectomy System
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP900056
Supplement NumberS183
Date Received03/10/2020
Decision Date02/05/2021
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change in the core wire supplier to increase torqueability of the Rotawire guidewires (Floppy and Extra Support), and the associated rebranding of the Rotawire guidewires as the Rotawire Drive guidewires (Floppy and Extra Support).
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