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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
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR INC.
26531 ynez road, building g
mailing p.o. 9018
temecula, CA 92590-9018
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 report
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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