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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT
Generic Namestent, coronary
ApplicantCORDIS CORP.
14201 n.w. 60th ave.
miami lakes, FL 33014-5700
PMA NumberP900043
Date Received06/21/1990
Decision Date08/02/1994
Withdrawal Date 09/02/2008
Product Code MAF 
Docket Number 97M-0166
Notice Date 07/10/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S002 S003 S005 S007 S008 S009 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S044 
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