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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 BALLOON EXPANDABLE STENT
Classification Namestent, coronary
Generic Nameiliac stent
ApplicantCORDIS CORP.
PMA NumberP890017
Supplement NumberS009
Date Received05/26/2000
Decision Date07/11/2000
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revised instructions for use (ifu) for the cordis palmaz(tm) balloon expandable stent.
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