A process improvement to upgrade the sterilization vessel control system and associated mechanical components
| Device | ENROUTE TRANSCAROTID STENT SYSTEM |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | SILK ROAD MEDICAL, INC |
| Date Received | 2019-04-05 |
| Decision Date | 2019-04-30 |
| PMA | P140026 |
| Supplement | S012 |
| 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 | SILK ROAD MEDICAL, INC 735 North Pastoria Ave sunnyvale, CA 94085 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140026 | | Original Filing |
| S026 |
2022-12-08 |
30-day Notice |
| S025 |
2022-11-21 |
30-day Notice |
| S024 | | |
| S023 | | |
| S022 | | |
| S021 |
2022-06-13 |
30-day Notice |
| S020 | | |
| S019 |
2022-04-22 |
30-day Notice |
| S018 |
2021-04-05 |
30-day Notice |
| S017 |
2021-03-05 |
Special (immediate Track) |
| S016 | | |
| S015 |
2020-05-18 |
30-day Notice |
| S014 |
2019-12-17 |
Normal 180 Day Track No User Fee |
| S013 |
2019-08-05 |
30-day Notice |
| S012 |
2019-04-05 |
30-day Notice |
| S011 |
2018-12-04 |
30-day Notice |
| S010 |
2018-04-23 |
Normal 180 Day Track No User Fee |
| S009 |
2018-04-02 |
30-day Notice |
| S008 |
2018-01-29 |
30-day Notice |
| S007 | | |
| S006 |
2017-02-14 |
Normal 180 Day Track No User Fee |
| S005 |
2017-01-31 |
Normal 180 Day Track |
| S004 |
2017-01-09 |
30-day Notice |
| S003 |
2016-06-08 |
30-day Notice |
| S002 |
2016-03-07 |
Normal 180 Day Track No User Fee |
| S001 |
2015-06-05 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices