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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(R) BALLOON-EXPANDABLE STENT
Classification Namestent, coronary
Generic Nameballoon stent
ApplicantCORDIS CORP.
PMA NumberP890017
Supplement NumberS005
Date Received09/02/1998
Decision Date09/25/1998
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested that fda review a change involving the transfer of an intermediate manufacturing process. The electropolishing of the metal stent and post-polishing stent inspection operation will be transferred from corids corporation to one of the suppliers, norman noble, inc. Of cleveland, ohio.
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