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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)
Classification Namecatheter, peripheral, atherectomy
Generic Namerotational angioplasty system; atherectomy
Regulation Number870.4875
ApplicantHEARING TECH, INC.
PMA NumberP900056
Supplement NumberS009
Date Received12/08/1994
Decision Date08/14/1995
Product Code
MCW[ Registered Establishments with MCW ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in location for seamed corporation, the manufacturer of the console used with the rotablator syste, from 11810 north creek parkway north, bothell, washington, to west willows technology center, n. E. 87th street, redmond, washington.
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