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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™; ROTAPRO™ Rotational Atherectomy Systems
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
Two Scimed Pl.
Maple Grove, MN 55311
PMA NumberP900056
Supplement NumberS224
Date Received03/12/2026
Decision Date04/09/2026
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
transfer of manufacturing activities of the ROTAWIRE Drive guidewire and wireClip Torquer guidewire manipulation devices from the BSC Heredia, Costa Rica facility to the BSC Coyol, Costa Rica facility
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