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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.
 
Trade NameROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER
Classification Namecatheter, coronary, atherectomy
ApplicantBOSTON SCIENTIFIC CORP.
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: manufacturing
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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