RX ACCULINK CAROTID STENT SYSTEM

FDA Premarket Approval P040012 S034

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.

Pre-market Approval Supplement Details

Approval for the rx acculink carotid stent system. The device is indicated for high surgical risk and standard surgical risk patients as follows: high surgical risk -the rx acculink carotid stent system, used in conjunction with abbott vascular's accunet or emboshield family of embolic protection systems (eps), is indicated for the treatment of revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram or patients without neurological symptoms and >= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and patients must have a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at the target lesion. Standard surgical risk - the rx acculink carotid stent system, used in conjunction with the accunet embolic protection system (eps), is indicated for the treatment of patients at standard risk for adverse events from cartoid endarterectomy who require carotid revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and >= 70% stenosis of the common or internal carotid artery by ultrasound or >= 50% stenosis of the common or internal carotid artery by angiogram or patients without neurological symptoms and >= 70% stenosis of the common or internal carotid artery by ultrasound or >= 60% stenosis of the common or internal carotid artery by angiogram; and patients must have a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at the target lesion.

DeviceRX ACCULINK CAROTID STENT SYSTEM
Generic NameStent, Carotid
ApplicantABBOTT VASCULAR
Date Received2010-10-01
Decision Date2011-05-06
Notice Date2011-05-12
PMAP040012
SupplementS034
Product CodeNIM 
Docket Number11M-0343
Advisory CommitteeCardiovascular
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P040012Original Filing
S064 2022-11-21 135 Review Track For 30-day Notice
S063 2021-11-09 30-day Notice
S062 2021-09-20 30-day Notice
S061 2021-05-18 30-day Notice
S060 2020-09-08 30-day Notice
S059 2017-03-21 30-day Notice
S058 2016-10-03 Real-time Process
S057 2016-09-26 Normal 180 Day Track No User Fee
S056 2016-01-04 Normal 180 Day Track No User Fee
S055 2015-03-09 30-day Notice
S054 2015-01-14 30-day Notice
S053 2013-11-29 135 Review Track For 30-day Notice
S052 2013-07-29 30-day Notice
S051 2012-12-19 30-day Notice
S050 2012-10-31 Real-time Process
S049 2012-08-24 30-day Notice
S048 2012-06-13 30-day Notice
S047 2012-06-11 30-day Notice
S046 2012-06-06 Normal 180 Day Track No User Fee
S045 2012-05-24 30-day Notice
S044 2012-03-20 Normal 180 Day Track
S043 2011-11-21 30-day Notice
S042 2011-09-19 Normal 180 Day Track
S041 2011-08-02 30-day Notice
S040 2011-06-10 30-day Notice
S039 2011-06-09 135 Review Track For 30-day Notice
S038 2011-02-28 30-day Notice
S037 2011-02-28 30-day Notice
S036 2011-02-18 135 Review Track For 30-day Notice
S035 2010-10-05 30-day Notice
S034 2010-10-01 Panel Track
S033 2010-09-17 30-day Notice
S032 2010-05-03 135 Review Track For 30-day Notice
S031 2009-11-02 Normal 180 Day Track
S030 2009-07-06 30-day Notice
S029 2008-12-22 30-day Notice
S028 2008-11-10 30-day Notice
S027 2007-09-27 Normal 180 Day Track No User Fee
S026 2007-04-02 30-day Notice
S025 2006-12-21 30-day Notice
S024 2006-11-14 30-day Notice
S023 2006-08-02 30-day Notice
S022 2006-07-21 30-day Notice
S021
S020 2006-07-14 135 Review Track For 30-day Notice
S019 2006-07-14 135 Review Track For 30-day Notice
S018 2006-07-10 135 Review Track For 30-day Notice
S017 2006-06-30 Special (immediate Track)
S016 2006-06-29 Special (immediate Track)
S015 2006-03-01 135 Review Track For 30-day Notice
S014 2006-02-28 30-day Notice
S013 2006-02-28 30-day Notice
S012 2006-02-28 30-day Notice
S011 2006-02-28 30-day Notice
S010 2006-02-28 Real-time Process
S009 2006-02-28 135 Review Track For 30-day Notice
S008 2006-02-24 Special (immediate Track)
S007 2006-02-24 30-day Notice
S006 2006-02-24 30-day Notice
S005 2006-02-24 30-day Notice
S004 2006-02-24 30-day Notice
S003 2005-12-22 Normal 180 Day Track No User Fee
S002
S001 2004-09-16 Normal 180 Day Track No User Fee

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