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.
| Device | MULTI-LINK RX ULTRA™ Coronary Stent System |
| Generic Name | Stent, Coronary |
| Applicant | ABBOTT VASCULAR INC.26531 Ynez Roadtemecula, CA 92591 PMA NumberP970020 Supplement NumberS086 Date Received08/09/2022 Decision Date09/07/2022 Product Code MAF Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-09 |
| Decision Date | 2022-09-07 |
| PMA | P970020 |
| Supplement | S086 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 26531 Ynez Road temecula, CA 92591 PMA NumberP970020 Supplement NumberS086 Date Received08/09/2022 Decision Date09/07/2022 Product Code MAF Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement for The Addition Of Secondary Sterilization Equipment |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970020 | Original Filing | |
| S086 | 2022-08-09 | 30-day Notice |
| S085 | 2021-04-29 | 30-day Notice |
| S084 | 2019-11-15 | 30-day Notice |
| S083 | 2018-06-13 | 30-day Notice |
| S082 | 2016-12-06 | Normal 180 Day Track |
| S081 | 2015-01-14 | 30-day Notice |
| S080 | 2014-04-14 | 30-day Notice |
| S079 | 2014-03-10 | 30-day Notice |
| S078 | 2013-10-18 | 30-day Notice |
| S077 | 2013-06-06 | 135 Review Track For 30-day Notice |
| S076 | 2012-10-02 | 30-day Notice |
| S075 | 2012-09-28 | 30-day Notice |
| S074 | 2012-07-20 | 30-day Notice |
| S073 | 2012-02-28 | 30-day Notice |
| S072 | ||
| S071 | 2012-02-06 | 30-day Notice |
| S070 | 2012-02-01 | Normal 180 Day Track No User Fee |
| S069 | 2011-10-11 | 30-day Notice |
| S068 | 2011-08-30 | 30-day Notice |
| S067 | 2011-08-02 | 30-day Notice |
| S066 | 2011-07-18 | 30-day Notice |
| S065 | 2011-06-09 | 135 Review Track For 30-day Notice |
| S064 | 2011-05-09 | 135 Review Track For 30-day Notice |
| S063 | 2011-04-14 | 30-day Notice |
| S062 | 2011-03-18 | 30-day Notice |
| S061 | 2011-03-04 | 30-day Notice |
| S060 | ||
| S059 | 2010-11-15 | 30-day Notice |
| S058 | 2010-10-05 | 30-day Notice |
| S057 | 2010-09-17 | 30-day Notice |
| S056 | 2010-06-23 | 30-day Notice |
| S055 | 2010-03-23 | 30-day Notice |
| S054 | 2008-11-10 | 30-day Notice |
| S053 | 2008-11-05 | 30-day Notice |
| S052 | 2008-08-06 | 30-day Notice |
| S051 | 2007-11-02 | 30-day Notice |
| S050 | 2007-10-02 | 30-day Notice |
| S049 | 2007-09-24 | 30-day Notice |
| S048 | 2007-01-19 | 30-day Notice |
| S047 | 2006-06-12 | Special (immediate Track) |
| S046 | 2005-01-27 | Real-time Process |
| S045 | 2004-03-09 | Normal 180 Day Track No User Fee |
| S044 | 2003-05-13 | Normal 180 Day Track |
| S043 | 2003-02-19 | Normal 180 Day Track No User Fee |
| S042 | 2002-03-19 | Normal 180 Day Track |
| S041 | 2002-02-15 | Normal 180 Day Track |
| S040 | 2001-12-26 | Panel Track |
| S039 | 2001-11-27 | Normal 180 Day Track |
| S038 | 2001-11-23 | Normal 180 Day Track |
| S037 | 2001-10-12 | Normal 180 Day Track |
| S036 | 2001-08-07 | Real-time Process |
| S035 | 2001-08-06 | Real-time Process |
| S034 | 2001-07-16 | 30-day Notice |
| S033 | 2001-05-07 | Real-time Process |
| S032 | 2001-04-26 | 30-day Notice |
| S031 | 2001-04-11 | Real-time Process |
| S030 | 2001-02-05 | Real-time Process |
| S029 | 2001-01-25 | 30-day Notice |
| S028 | 2001-01-25 | Normal 180 Day Track |
| S027 | 2001-01-16 | Real-time Process |
| S026 | 2000-11-06 | 30-day Notice |
| S025 | ||
| S024 | 2000-05-30 | Real-time Process |
| S023 | 2000-04-12 | Normal 180 Day Track |
| S022 | 2000-04-06 | Normal 180 Day Track |
| S021 | 2000-03-17 | Normal 180 Day Track |
| S020 | 2000-02-23 | 30-day Notice |
| S019 | 1999-12-06 | 30-day Notice |
| S018 | 1999-07-14 | 30-day Notice |
| S017 | 1999-06-21 | Normal 180 Day Track |
| S016 | ||
| S015 | 1999-04-27 | 30-day Notice |
| S014 | 1999-04-16 | 30-day Notice |
| S013 | ||
| S012 | 1999-03-29 | 30-day Notice |
| S011 | 1999-02-26 | Normal 180 Day Track |
| S010 | ||
| S009 | 1998-12-28 | Special (immediate Track) |
| S008 | 1998-12-28 | 30-day Notice |
| S007 | 1998-12-08 | Normal 180 Day Track |
| S006 | 1998-10-19 | 30-day Notice |
| S005 | 1998-08-17 | Normal 180 Day Track |
| S004 | 1998-05-14 | Normal 180 Day Track |
| S003 | 1998-05-11 | Normal 180 Day Track |
| S002 | 1998-02-24 | Normal 180 Day Track |
| S001 | 1998-02-03 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 08717648035494 | P970020 | 021 |
| 08717648035272 | P970020 | 021 |
| 08717648035289 | P970020 | 021 |
| 08717648035296 | P970020 | 021 |
| 08717648035302 | P970020 | 021 |
| 08717648035319 | P970020 | 021 |
| 08717648035326 | P970020 | 021 |
| 08717648035333 | P970020 | 021 |
| 08717648035425 | P970020 | 021 |
| 08717648035432 | P970020 | 021 |
| 08717648035449 | P970020 | 021 |
| 08717648035456 | P970020 | 021 |
| 08717648035463 | P970020 | 021 |
| 08717648035470 | P970020 | 021 |
| 08717648035487 | P970020 | 021 |
| 08717648035265 | P970020 | 021 |