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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 NumberS002
Date Received08/27/1996
Decision Date09/17/1996
Withdrawal Date 09/06/2007
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
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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