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.
| Device | Wallstent™ Venous Endoprosthesis with Unistep Plus™ Delivery System |
| Generic Name | Stent, Central Venous |
| Applicant | BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311-1566 PMA NumberP980033 Supplement NumberS059 Date Received06/03/2022 Decision Date06/28/2022 Product Code QKJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-03 |
| Decision Date | 2022-06-28 |
| PMA | P980033 |
| Supplement | S059 |
| Product Code | QKJ |
| 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 CORPORATION one Scimed Place maple Grove, MN 55311-1566 PMA NumberP980033 Supplement NumberS059 Date Received06/03/2022 Decision Date06/28/2022 Product Code QKJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of A Delivery System Distal Tip Supplier |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980033 | Original Filing | |
| S061 | 2022-11-14 | 30-day Notice |
| S060 | 2022-09-14 | 30-day Notice |
| S059 | 2022-06-03 | 30-day Notice |
| S058 | 2020-07-10 | 30-day Notice |
| S057 | 2020-06-16 | 30-day Notice |
| S056 | 2019-09-30 | 30-day Notice |
| S055 | 2019-06-27 | 30-day Notice |
| S054 | 2019-05-03 | 30-day Notice |
| S053 | 2019-03-22 | 30-day Notice |
| S052 | 2018-11-21 | 30-day Notice |
| S051 | 2018-11-21 | 30-day Notice |
| S050 | ||
| S049 | 2017-06-19 | 30-day Notice |
| S048 | 2017-06-01 | 30-day Notice |
| S047 | 2016-10-03 | 30-day Notice |
| S046 | 2016-09-13 | 30-day Notice |
| S045 | 2016-07-26 | 30-day Notice |
| S044 | ||
| S043 | 2015-03-09 | Real-time Process |
| S042 | ||
| S041 | 2014-04-25 | 30-day Notice |
| S040 | 2013-11-26 | 30-day Notice |
| S039 | 2013-11-25 | 30-day Notice |
| S038 | 2013-11-04 | 30-day Notice |
| S037 | 2013-09-20 | 30-day Notice |
| S036 | 2013-08-29 | 30-day Notice |
| S035 | 2013-06-19 | 30-day Notice |
| S034 | 2013-06-10 | 30-day Notice |
| S033 | 2013-05-28 | 30-day Notice |
| S032 | 2013-05-09 | 30-day Notice |
| S031 | 2013-03-21 | 30-day Notice |
| S030 | 2013-01-15 | 30-day Notice |
| S029 | 2012-11-27 | 135 Review Track For 30-day Notice |
| S028 | 2012-11-19 | 30-day Notice |
| S027 | 2012-11-19 | 30-day Notice |
| S026 | 2012-10-15 | 30-day Notice |
| S025 | 2012-09-28 | 30-day Notice |
| S024 | 2012-09-05 | 30-day Notice |
| S023 | 2012-08-13 | 30-day Notice |
| S022 | 2012-06-15 | 30-day Notice |
| S021 | 2012-06-13 | 30-day Notice |
| S020 | 2012-04-18 | 30-day Notice |
| S019 | 2011-07-07 | 30-day Notice |
| S018 | 2011-02-10 | 135 Review Track For 30-day Notice |
| S017 | 2010-04-08 | 135 Review Track For 30-day Notice |
| S016 | 2010-01-26 | 30-day Notice |
| S015 | 2008-11-19 | 30-day Notice |
| S014 | 2006-05-09 | 30-day Notice |
| S013 | 2005-03-14 | Normal 180 Day Track No User Fee |
| S012 | 2004-12-20 | 30-day Notice |
| S011 | 2004-06-25 | 30-day Notice |
| S010 | 2004-04-09 | 30-day Notice |
| S009 | 2003-12-08 | 30-day Notice |
| S008 | 2003-11-17 | Normal 180 Day Track No User Fee |
| S007 | 2003-08-14 | 30-day Notice |
| S006 | 2003-03-12 | Special (immediate Track) |
| S005 | 2002-12-18 | 30-day Notice |
| S004 | 2002-12-12 | 30-day Notice |
| S003 | 2002-05-29 | 30-day Notice |
| S002 | 2002-04-24 | Normal 180 Day Track |
| S001 | 2001-12-20 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729979647 | P980033 | 050 |
| 08714729979500 | P980033 | 050 |
| 08714729979494 | P980033 | 050 |
| 08714729979487 | P980033 | 050 |
| 08714729979470 | P980033 | 050 |
| 08714729979463 | P980033 | 050 |
| 08714729979456 | P980033 | 050 |
| 08714729979449 | P980033 | 050 |
| 08714729979432 | P980033 | 050 |
| 08714729979425 | P980033 | 050 |
| 08714729979418 | P980033 | 050 |
| 08714729979517 | P980033 | 050 |
| 08714729979524 | P980033 | 050 |
| 08714729979531 | P980033 | 050 |
| 08714729979630 | P980033 | 050 |
| 08714729979623 | P980033 | 050 |
| 08714729979616 | P980033 | 050 |
| 08714729979609 | P980033 | 050 |
| 08714729979593 | P980033 | 050 |
| 08714729979586 | P980033 | 050 |
| 08714729979579 | P980033 | 050 |
| 08714729979562 | P980033 | 050 |
| 08714729979555 | P980033 | 050 |
| 08714729979548 | P980033 | 050 |
| 08714729979401 | P980033 | 050 |