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.
Approval for modifications to the indication statement and instructions for use to incorporate use with the emboshield embolic protection system. The device, as modified, willbe marketed under the trade name rx acculink carotid stem system and is indicated for usein conjunction with abbott vascular's accunet or emboshield family of embolic protectionsystems, for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria as previously approved.
Device | RX ACCULINK CAROTID STENT SYSTEM |
Generic Name | Stent, Carotid |
Applicant | ABBOTT VASCULAR |
Date Received | 2009-11-02 |
Decision Date | 2010-04-30 |
PMA | P040012 |
Supplement | S031 |
Product Code | NIM |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054 |
Supplement Number | Date | Supplement Type |
---|---|---|
P040012 | Original 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 |