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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 NamePALMZ BALLOON EXPANDABLE STENTS
Classification Namestent, coronary
Generic Nameiliac stent
ApplicantCORDIS CORP.
PMA NumberP890017
Supplement NumberS008
Date Received03/23/2000
Decision Date07/11/2000
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the device labeling to specify the cordis maxi ds balloon catheter as the recommended delivery system for the p308 palmaz(tm) balloon expandable stent.
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