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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 STENTS
Classification Namestent, coronary
Generic Nameiliac stent
ApplicantCORDIS CORP., A JOHNSON & JOHNSON CO.
PMA NumberP890017
Supplement NumberS011
Date Received04/15/2003
Decision Date07/15/2003
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 
Approval for a new manufacturing facility located at norman noble, inc. , highland heights, ohio.
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