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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'S DYNAGLIDE(TM) FOOT PEDAL
Classification Namecatheter, coronary, atherectomy
Generic Namerotational angioplasty system; atherectomy
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Supplement NumberS015
Date Received01/17/1996
Decision Date04/23/1996
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Elimination of the usp mouse safety test as a sterilization load release crieteria.
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