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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.
 
DevicePALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP900043
Supplement NumberS012
Date Received06/26/1998
Decision Date08/04/1998
Withdrawal Date09/02/2008
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the indication of treatment of restenotic native coronary artery lesions with arefernce diameter in the range of 3-4 mm, and modifications ot the current albel that include addition ofthe Stars Trial results to the clinical summary section.
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