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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceIVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantIntensive Technology, Inc.
3574 Ruffin Rd.
San Diego, CA 92123
PMA NumberP910019
Supplement NumberS001
Date Received06/13/1994
Decision Date01/05/1995
Withdrawal Date09/06/2007
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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