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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 NameBIODIVYSIOI AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantEMINENT RESEARCH SYSTEMS
PMA NumberP000011
Supplement NumberS001
Date Received11/01/2000
Decision Date05/07/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study protocol for the biodivysio(tm) as pc (phosphorylcholine) coated stent and delivery system.
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