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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameballoon stent
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS012
Date Received06/26/1998
Decision Date08/04/1998
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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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