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 the addition of two manufacturing facilities located at boston scientific corp. , quincy, massachusetts and boston scientific european distribution center, maastricht-airport, the netherlands. These facilities will perform packaging and labeling operations for the wallstent endoprosthesis with the unistep plus delivery system.
| Device | WALL STENT ILIAC ENDOPROSTHESIS |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. |
| Date Received | 2003-11-17 |
| Decision Date | 2003-12-11 |
| PMA | P940019 |
| Supplement | S016 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Express Gmp Supplement |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC SCIMED, INC. one Scimed Place maple Grove, MN 55311-1566 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940019 | Original Filing | |
| S062 | 2022-11-14 | 30-day Notice |
| S061 | 2022-10-27 | 30-day Notice |
| S060 | 2022-06-03 | 30-day Notice |
| S059 | 2020-07-10 | 30-day Notice |
| S058 | 2020-06-16 | 30-day Notice |
| S057 | 2019-09-30 | 30-day Notice |
| S056 | 2019-06-27 | 30-day Notice |
| S055 | 2019-05-03 | 30-day Notice |
| S054 | 2019-03-22 | 30-day Notice |
| S053 | 2018-11-21 | 30-day Notice |
| S052 | 2018-11-21 | 30-day Notice |
| S051 | 2017-06-19 | 30-day Notice |
| S050 | 2017-06-01 | 30-day Notice |
| S049 | 2016-10-03 | 30-day Notice |
| S048 | 2016-09-13 | 30-day Notice |
| S047 | 2016-07-26 | 30-day Notice |
| S046 | ||
| S045 | ||
| S044 | 2014-04-25 | 30-day Notice |
| S043 | 2013-11-26 | 30-day Notice |
| S042 | 2013-11-25 | 30-day Notice |
| S041 | 2013-09-20 | 30-day Notice |
| S040 | 2013-08-29 | 30-day Notice |
| S039 | 2013-06-10 | 30-day Notice |
| S038 | 2013-05-28 | 30-day Notice |
| S037 | 2013-05-09 | 30-day Notice |
| S036 | 2013-03-21 | 30-day Notice |
| S035 | 2012-11-27 | 135 Review Track For 30-day Notice |
| S034 | 2012-11-19 | 30-day Notice |
| S033 | 2012-11-19 | 30-day Notice |
| S032 | 2012-10-15 | 30-day Notice |
| S031 | 2012-09-28 | 30-day Notice |
| S030 | 2012-09-05 | 30-day Notice |
| S029 | 2012-08-13 | 30-day Notice |
| S028 | 2012-06-15 | 30-day Notice |
| S027 | 2012-06-13 | 30-day Notice |
| S026 | 2011-07-07 | 30-day Notice |
| S025 | 2011-06-20 | Real-time Process |
| S024 | 2011-02-10 | 135 Review Track For 30-day Notice |
| S023 | 2010-04-08 | 135 Review Track For 30-day Notice |
| S022 | 2010-01-26 | 30-day Notice |
| S021 | 2007-08-13 | Special (immediate Track) |
| S020 | 2006-05-09 | 30-day Notice |
| S019 | 2005-03-14 | Normal 180 Day Track No User Fee |
| S018 | 2004-12-20 | 30-day Notice |
| S017 | 2003-12-08 | 30-day Notice |
| S016 | 2003-11-17 | Normal 180 Day Track No User Fee |
| S015 | 2003-08-14 | 30-day Notice |
| S014 | 2002-12-18 | 30-day Notice |
| S013 | 2002-12-12 | 30-day Notice |
| S012 | 2002-05-29 | 30-day Notice |
| S011 | 2002-04-24 | Normal 180 Day Track |
| S010 | 2002-01-09 | Special (immediate Track) |
| S009 | 2001-12-20 | Normal 180 Day Track |
| S008 | 2001-07-12 | Special (immediate Track) |
| S007 | 2001-05-03 | 30-day Notice |
| S006 | ||
| S005 | 1999-09-01 | Normal 180 Day Track |
| S004 | 1998-09-14 | Normal 180 Day Track |
| S003 | 1996-12-23 | Normal 180 Day Track |
| S002 | 1996-10-15 | Normal 180 Day Track |
| S001 |