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.
Change in the manufacturing process which involved the use of an alternate biological indicator (bi) with a shorter labeled incubation time of four (4) hours for use in monitoring the eo sterilization cycles and sterilization process validation.
| Device | WALLENSTENT TIPS ENDOPROSTHESIS |
| Classification Name | Shunt, Portosystemic, Endoprosthesis |
| Generic Name | Shunt, Portosystemic, Endoprosthesis |
| Applicant | Boston Scientific Corp. |
| Date Received | 2003-12-08 |
| Decision Date | 2004-01-07 |
| PMA | P930031 |
| Supplement | S020 |
| Product Code | MIR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930031 | Original Filing | |
| S071 | 2022-11-14 | 30-day Notice |
| S070 | 2022-10-27 | 30-day Notice |
| S069 | 2022-06-03 | 30-day Notice |
| S068 | 2020-07-10 | 30-day Notice |
| S067 | 2020-06-16 | 30-day Notice |
| S066 | 2019-09-30 | 30-day Notice |
| S065 | 2019-06-27 | 30-day Notice |
| S064 | 2019-05-03 | 30-day Notice |
| S063 | 2019-03-22 | 30-day Notice |
| S062 | 2018-11-21 | 30-day Notice |
| S061 | 2018-11-21 | 30-day Notice |
| S060 | 2017-06-19 | 30-day Notice |
| S059 | 2017-06-01 | 30-day Notice |
| S058 | 2016-10-03 | 30-day Notice |
| S057 | 2016-09-13 | 30-day Notice |
| S056 | 2016-07-26 | 30-day Notice |
| S055 | ||
| S054 | 2015-03-09 | Real-time Process |
| S053 | ||
| S052 | 2014-04-25 | 30-day Notice |
| S051 | 2013-11-26 | 30-day Notice |
| S050 | 2013-11-25 | 30-day Notice |
| S049 | 2013-11-04 | 30-day Notice |
| S048 | 2013-09-20 | 30-day Notice |
| S047 | 2013-08-29 | 30-day Notice |
| S046 | 2013-06-19 | 30-day Notice |
| S045 | 2013-06-10 | 30-day Notice |
| S044 | 2013-05-28 | 30-day Notice |
| S043 | 2013-05-09 | 30-day Notice |
| S042 | 2013-03-21 | 30-day Notice |
| S041 | 2013-01-15 | 30-day Notice |
| S040 | 2012-11-27 | 135 Review Track For 30-day Notice |
| S039 | 2012-11-19 | 30-day Notice |
| S038 | 2012-11-19 | 30-day Notice |
| S037 | 2012-10-15 | 30-day Notice |
| S036 | 2012-09-28 | 30-day Notice |
| S035 | 2012-09-05 | 30-day Notice |
| S034 | 2012-08-13 | 30-day Notice |
| S033 | 2012-06-15 | 30-day Notice |
| S032 | 2012-06-13 | 30-day Notice |
| S031 | 2012-04-18 | 30-day Notice |
| S030 | 2011-07-07 | 30-day Notice |
| S029 | 2011-02-10 | 135 Review Track For 30-day Notice |
| S028 | 2010-04-08 | 135 Review Track For 30-day Notice |
| S027 | 2010-01-26 | 30-day Notice |
| S026 | 2008-11-19 | 30-day Notice |
| S025 | 2006-05-09 | 30-day Notice |
| S024 | 2005-03-14 | Normal 180 Day Track No User Fee |
| S023 | 2004-12-20 | 30-day Notice |
| S022 | 2004-06-25 | 30-day Notice |
| S021 | 2004-04-09 | 30-day Notice |
| S020 | 2003-12-08 | 30-day Notice |
| S019 | ||
| S018 | 2003-11-17 | Normal 180 Day Track No User Fee |
| S017 | 2003-08-14 | 30-day Notice |
| S016 | 2002-12-18 | 30-day Notice |
| S015 | 2002-12-12 | 30-day Notice |
| S014 | 2002-05-29 | 30-day Notice |
| S013 | 2002-04-24 | Normal 180 Day Track |
| S012 | 2002-01-09 | Special (immediate Track) |
| S011 | 2001-12-20 | Normal 180 Day Track |
| S010 | 2001-07-12 | Special (immediate Track) |
| S009 | 2001-05-03 | 30-day Notice |
| S008 | ||
| S007 | 1999-09-01 | Normal 180 Day Track |
| S006 | 1998-08-12 | Normal 180 Day Track |
| S005 | 1998-04-22 | Normal 180 Day Track |
| S004 | 1996-10-15 | Normal 180 Day Track |
| S003 | 1996-05-13 | Normal 180 Day Track |
| S002 | 1996-04-04 | Normal 180 Day Track |
| S001 | 1995-10-04 | Normal 180 Day Track |