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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 NumberS008
Date Received12/15/1997
Decision Date06/08/1998
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 a reference diameter in the range of 3-4 mm, and modifications to the current label that include addition of the stars trial results to the clinical summary section.
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