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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 CONSOLE AND DYNAGLIDE(TM)FOOT PEDAL
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP900056
Supplement NumberS064
Date Received05/30/2001
Decision Date09/07/2001
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITIES LOCATED AT PLEXUS CORPORATION, BOTHELL, WASHINGTON FOR THE MANUFACTURE OF THE ROTABLATOR(R) CONSOLE AND DYNAGLIDE(TM) FOOT PEDAL AND BOSTON SCIENTIFIC SCIMED IVUS TECHNOLOGY CENTER, FREMONT, CALIFORNIA FO RINSPECTION FUNCTIONS.
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