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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) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP900056
Supplement NumberS018
Date Received06/20/1996
Decision Date02/13/1997
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ROTALINK(TM) EXCHANGEABLE CATHETER FOR THE ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM AND IS INDICATED FOR USE IN PATIENTS WITH CORONARY ARTERY DISEASE SHO ARE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG) SRUGERY AND WHO MEET ONE OF THE FOLLOWING CRITERIA:SINGLE VESSEL ATHEROSCLEROTIC CORONARY ARTERY DISEASE WITH A STENOSIS THAT CAN BE PASSED WITH A GUIDE WIRE; MULTIPLE VESSEL CORONARY ARTERY DISEASE THAT IN THE PHYSICIAN'S JUDGMENT DOES NOT POSE UNDO RISK TO THE PATIENT; CERTAIN PATIENTS WITH PREVIOUS PTCA, AND WHO HAVE A RESTENOSIS OF THE NATIVE VESSEL; OR NATIVE VESSEL ATHEROSCLEROTIC CORONARY ARTERY DISEASE THAT IS LESS THAN 25 MM IN LENGTH.
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