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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.
 
DeviceBIODIVYSIO OC/OTW STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD, BUILDING G
MAILING P.O. 9018
TEMECULA, CA 92590-9018
PMA NumberP000011
Supplement NumberS004
Date Received08/31/2001
Decision Date03/01/2002
Withdrawal Date 09/05/2014
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE BIODIVYSIO OC OTW IN 11 MM, 15 MM, 18 MM, 22 MM AND 28 MM STENT LENGTHS AND 3.0 MM, 3.5 MM AND 4.0 MM DIAMETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO OC OTW AND IS INDICATED FOR: "USE IN SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >= 3.0 MM TO <= 4.0 MM AND INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT."
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