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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 NumberS046
Date Received05/19/2000
Decision Date06/13/2000
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATE VENDOR FOR THE BAKE HYPO TUBES USED IN THE MANUFACTURING OF THE ROTABLATOR ROTALINK ADVANCER AND PASSIVATED AT THE VENDOR, AN ADDITIONAL MANUFACTURING STEP FOR THE COMPONENT.
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