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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(R) ROTALINK EXCHANGEABLE CATHETER
Classification Namecatheter, coronary, atherectomy
Generic Namerotablator rotational angioplasty system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS059
Date Received12/06/2000
Decision Date12/29/2000
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the manufacturing process for the rotablator rotalink advancer. The change will increase the pressure with which the front plug is pressed into the turbine housing.
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