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 | ENROUTE® Transcarotid Stent System |
| Generic Name | Stent, Carotid |
| Applicant | SILK ROAD MEDICAL, INC735 North Pastoria Avesunnyvale, CA 94085 PMA NumberP140026 Supplement NumberS021 Date Received06/13/2022 Decision Date06/24/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-13 |
| Decision Date | 2022-06-24 |
| PMA | P140026 |
| Supplement | S021 |
| 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 PMA NumberP140026 Supplement NumberS021 Date Received06/13/2022 Decision Date06/24/2022 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 updating The Final Goods Work Instructions To Remove Redundant Inspections And Administrative Updates |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00811311020539 | P140026 | 000 |
| 00811311020362 | P140026 | 000 |
| 00811311020379 | P140026 | 000 |
| 00811311020386 | P140026 | 000 |
| 00811311020393 | P140026 | 000 |
| 00811311020409 | P140026 | 000 |
| 00811311020416 | P140026 | 000 |
| 00811311020423 | P140026 | 000 |
| 00811311020430 | P140026 | 000 |
| 00811311020447 | P140026 | 000 |
| 00811311020454 | P140026 | 000 |
| 00811311020522 | P140026 | 000 |
| 00811311020515 | P140026 | 000 |
| 00811311020508 | P140026 | 000 |
| 00811311020492 | P140026 | 000 |
| 00811311020485 | P140026 | 000 |
| 00811311020478 | P140026 | 000 |
| 00811311020461 | P140026 | 000 |
| 00811311021277 | P140026 | 024 |
| 00811311021284 | P140026 | 024 |
| 00811311021291 | P140026 | 024 |
| 00811311021307 | P140026 | 024 |
| 00811311021314 | P140026 | 024 |
| 00811311021321 | P140026 | 024 |
| 00811311021260 | P140026 | 024 |