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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 NameIVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Classification Namecatheter, coronary, atherectomy
Generic Nameatherectomy system
ApplicantBOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
PMA NumberP910019
Supplement NumberS004
Date Received10/30/1997
Decision Date12/30/1998
Product Code
MCX[ Registered Establishments with MCX ]
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 a change to the tec system power pack circuitry involving the replacement of the current analog motor control circuitry (integrated circuit, lm1014n-2) with new digital circuitry (integrated circuit microcontroller, pic16c711).
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