Approval for the addition of a new indication for the acs multi-link rx and otw d, tristar, ultr tetra coronary stent systems and acs multi-link. Stent and the four delivery systems. The new additional indication for these devices is for use in patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length = 25 mm) with a reference vessel diameter of 3. 0 mm to 4. 0 mm.
| Device | ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2001-04-11 |
| Decision Date | 2001-06-05 |
| PMA | P970020 |
| Supplement | S031 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 26531 Ynez Road temecula, CA 92591 |
Supplemental Filings
| 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 |
NIH GUDID Devices