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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 NameCORDIS PALMAZ BALLOON-EXPANDABLE STENT FOR THE ILIAC AND RENAL ARTERIES
Classification Namestent, coronary
Generic Nameiliac stent
ApplicantCORDIS CORP., A JOHNSON & JOHNSON CO.
PMA NumberP890017
Supplement NumberS014
Date Received01/20/2006
Decision Date04/21/2006
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the bacterial endotoxin test method to the kinetic chromogenic lal test method, per 2005 usp 28, nf23, chapter <85>.
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