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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/ILIAC ARTERIES
Classification Namestent, coronary
Generic Nameballoon stent
ApplicantCORDIS CORP.
PMA NumberP890017
Supplement NumberS004
Date Received02/22/1994
Decision Date05/20/1996
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate manufacturing facility for finishing, packaging, and distribution of the device.
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