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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT
Classification Namestent, coronary
Generic Nameballoon stent
ApplicantCORDIS CORP.
PMA NumberP900043
Date Received06/21/1990
Decision Date08/02/1994
Withdrawal Date 09/02/2008
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 97M-0166
Notice Date 07/10/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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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