Approval for the acs multi-link rx duet(tm) and acs multi-link otw duet(tm) coronary stent systems. These devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic lesions in native coronary arteries (length < 25mm) with a reference vessel diameter ranging from 3. 0 mm to 4. 0 mm.
| Device | ACS MULTI-LINK RX DUET TM AND ACS MULTI-LINK OTW DUET TM CORONARY STENT SYSTEMS |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 1998-05-14 |
| Decision Date | 1998-11-05 |
| PMA | P970020 |
| Supplement | S004 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |
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