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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter, coronary, atherectomy
Applicant
Boston Scientific Corp.
two scimed place
maple grove, MN 55311-1566
PMA NumberP900056
Supplement NumberS020
Date Received09/26/1996
Decision Date05/13/1997
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional contract sterilization facility, sorex medical, salt lake city, utah.
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