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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 NumberS002
Date Received08/27/1996
Decision Date09/17/1996
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the rear seal assembly of the tec drive component of the tec coronary atherectomy system.
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