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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameIVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Classification Namecatheter, coronary, atherectomy
Generic Nameatherectomy system
ApplicantINTENSIVE TECHNOLOGY, INC.
PMA NumberP910019
Date Received03/29/1991
Decision Date05/18/1993
Withdrawal Date 09/06/2007
Product Code
MCX[ Registered Establishments with MCX ]
Docket Number 93M-0209
Notice Date 07/27/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 
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