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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
Classification Namecatheter, peripheral, atherectomy
Regulation Number870.4875
ApplicantHEARING TECH, INC.
PMA NumberP900056
Supplement NumberS014
Date Received01/11/1996
Decision Date05/16/1996
Product Code
MCW[ Registered Establishments with MCW ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the support rotawire and rail rotawire guide wires for use with the rotablator rotational angioplasty system.
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