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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) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS
Classification Namecatheter, coronary, atherectomy
Generic Namerotablator rotational angioplasty system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS065
Date Received06/12/2001
Decision Date07/16/2001
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 an alternate manufacturing site located at boston scientific, ltd. , cork, ireland.
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