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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 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-5700
PMA NumberP900043
Supplement NumberS007
Date Received07/23/1997
Decision Date12/19/1997
Withdrawal Date 09/02/2008
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Palmaz-Schatz(TM) Crown balloon expandable stent in diameters of 3.0, 3.5, and 4.0 mm and lengths of 15, 22 and 30 mm. In addition approval for primary stenting of de novo lesions up to 25 mm in length and other modifications to the current label.
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