Requested a change in manufacturing equipment used to coat the stent delivery system and balloon dilatation catheters.
| Device | MULTI-LINK ZETA CORONARY STENT SYSTEMS (CSS) |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2010-03-23 |
| Decision Date | 2010-04-23 |
| PMA | P970020 |
| Supplement | S055 |
| 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 |
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