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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(R) ROTALINK EXCHANGEABLE CATHETER
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP900056
Supplement NumberS058
Date Received11/17/2000
Decision Date12/12/2000
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE TO THE MANUFACTURING PROCESS FOR THE ROTABLATOR ROTALINK EXCHANGEABLE CATHETER TO INCREASE THE MAXIMUM ALLOWED ENERGY USED DURING THE LASER WELD PROCESS ON THE CATHETER DRIVE ASSEMBLY HANDSHAKE.
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