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 changes to the manufacturing process for bonding the tip bump to the guidewire lumen in rx acculink and acculink carotid stents.
| Device | RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS |
| Generic Name | Stent, Carotid |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2006-07-14 |
| Decision Date | 2006-09-20 |
| PMA | P040012 |
| Supplement | S019 |
| Product Code | NIM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |