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 | Carotid WALLSTENT Monorail Endoprosthesis |
| Generic Name | Stent, Carotid |
| Applicant | Boston Scientific Corp.three Scimed Placemaple Grove, MN 55311-1566 PMA NumberP050019 Supplement NumberS034 Date Received02/22/2022 Decision Date03/24/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-03-24 |
| PMA | P050019 |
| Supplement | S034 |
| Product Code | NIM |
| 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. three Scimed Place maple Grove, MN 55311-1566 PMA NumberP050019 Supplement NumberS034 Date Received02/22/2022 Decision Date03/24/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement vendor Manufacturing Site And Die Cutting Process Changes For A Packaging Component |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050019 | Original Filing | |
| S036 | 2022-11-14 | 30-day Notice |
| S035 | ||
| S034 | 2022-02-22 | 30-day Notice |
| S033 | 2021-11-12 | 30-day Notice |
| S032 | 2021-10-19 | 30-day Notice |
| S031 | 2019-06-27 | 30-day Notice |
| S030 | 2018-02-21 | 30-day Notice |
| S029 | 2018-01-26 | 30-day Notice |
| S028 | 2017-06-19 | 30-day Notice |
| S027 | ||
| S026 | 2016-11-14 | 30-day Notice |
| S025 | 2016-07-13 | 30-day Notice |
| S024 | 2016-02-25 | 30-day Notice |
| S023 | 2015-11-20 | 30-day Notice |
| S022 | 2015-11-19 | 30-day Notice |
| S021 | 2015-02-23 | Real-time Process |
| S020 | ||
| S019 | 2013-09-27 | 30-day Notice |
| S018 | 2013-09-20 | 30-day Notice |
| S017 | 2013-08-29 | 30-day Notice |
| S016 | 2013-06-19 | 30-day Notice |
| S015 | 2013-06-10 | 30-day Notice |
| S014 | 2013-05-28 | 30-day Notice |
| S013 | 2013-02-04 | 30-day Notice |
| S012 | 2012-11-19 | 30-day Notice |
| S011 | 2012-11-01 | 30-day Notice |
| S010 | 2012-08-13 | 30-day Notice |
| S009 | 2012-06-13 | 30-day Notice |
| S008 | 2011-07-15 | Normal 180 Day Track No User Fee |
| S007 | 2011-04-01 | 30-day Notice |
| S006 | 2010-10-07 | Normal 180 Day Track No User Fee |
| S005 | 2010-04-08 | 135 Review Track For 30-day Notice |
| S004 | 2010-02-01 | Normal 180 Day Track |
| S003 | 2010-01-26 | 30-day Notice |
| S002 | 2009-12-15 | 30-day Notice |
| S001 | 2009-05-19 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729781226 | P050019 | 000 |
| 08714729781202 | P050019 | 000 |
| 08714729781189 | P050019 | 000 |
| 08714729781165 | P050019 | 000 |
| 08714729781141 | P050019 | 000 |
| 08714729781127 | P050019 | 000 |
| 08714729781103 | P050019 | 000 |