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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIODIVYSIOI AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd., Bldg. G, Mailing P.O. 9018
Temecula, CA 92590
PMA NumberP000011
Supplement NumberS001
Date Received11/01/2000
Decision Date05/07/2001
Withdrawal Date09/05/2014
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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