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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 NumberS005
Date Received01/16/1997
Decision Date03/13/1997
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the balloon folding and stent crimping manufacturing process and the addition of a new stent retention test.
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