Approval for a modified test method and specification extractables testing of pebax resin material.
| Device | CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | Boston Scientific Corp. |
| Date Received | 2010-04-08 |
| Decision Date | 2011-01-07 |
| PMA | P050019 |
| Supplement | S005 |
| Product Code | NIM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices