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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 ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter, coronary, atherectomy
Applicant
Boston Scientific Corp.
two scimed place
maple grove, MN 55311-1566
PMA NumberP900056
Supplement NumberS093
Date Received05/23/2008
Decision Date09/30/2008
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing process change to eliminate a parts cleaning process for select components.
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