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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 NumberS003
Date Received10/28/1997
Decision Date01/29/1998
Withdrawal Date09/06/2007
Product Code MCX 
Docket Number N
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the 5.5F TEC(R) cutter catheter, involving an increase in the skirt length of the cutter component from 0.079 inches to 0.104 inches.
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