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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 ROTATIONAL ANGIOPLASTY SYSTEM AND ROTALINK(TM) PLUS WITH EXCHANGEABLE CATHETER
Classification Namecatheter, coronary, atherectomy
Generic Namerotablator rotational angioplasty system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS060
Date Received02/06/2001
Decision Date03/21/2001
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at boston scientific cork ltd. (bscl), cork, ireland and a sterilization facility located at isotron ireland ltd. , offaly, ireland.
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