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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.
 
DeviceROTAGLIDE(TM) LUBRICANT
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP900056
Supplement NumberS045
Date Received05/18/2000
Decision Date06/06/2000
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES IN THE MANUFACTURING PROCESS, REMOVING ONE OF THE STEPS FROM THE RELEASE CRITERIA FOR ROTAGLIDE(TM) LUBRICANT, TO MOVE THE PACKAGING INSPECTION AND REVIEW OF THE CERTIFICATE OF ANALYSIS FROM BOSTON SCIENTIFIC CORP. NORTHWEST TO BOSTON SCIENTIFIC CORP'S MARINA BAY DISTRIBUTION CENTER IN QUINCY, MASSECHUSETTS.
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