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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.
 
DevicePHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD, BUILDING G
MAILING P.O. 9018
TEMECULA, CA 92590-9018
PMA NumberP000011
Supplement NumberS003
Date Received06/28/2001
Decision Date12/21/2001
Withdrawal Date 09/05/2014
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR: 1) THE BIODIVYSIO(TM) SV OTW IN 10 MM, 15 MM AND 18 MM STENT LENGTHS AND 2.0 MM AND 2.5 MM DIAMETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO(TM) SV OTW AND IS INDICATED FOR "IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS EXPERIENCING ABRUPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >=2.0 MM TO <=3.0 MM BY VISUAL ESTIMATE. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT." 2) THE BIODIVYSIO(TM) AS OTW IN 11 MM AND 15 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(TM) AS OTW AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: A)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; B)SUBJECTS EXPERIENCING ABURPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH REFERENCE VESSEL DIAMETER RANGING FROM >=3.0 MM TO <=4.0 MM BY VISUAL ESTIMATION. LONG TERM OUTCOME (BEYOND 6 MONTHS) FOR THESE PERMANENT IMPLANTS ARE UNKNOWN AT PRESENT.
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