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 | S.M.A.R.T. RADIANZ Vascular Stent System |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP120002 Supplement NumberS020 Date Received09/01/2021 Decision Date02/25/2022 Product Code NIP Advisory Committee Cardiovascular Clinical TrialsNCT00739102 Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2021-09-01 |
| Decision Date | 2022-02-25 |
| PMA | P120002 |
| Supplement | S020 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis US Corporation 14201 Nw 60th Avenue miami Lakes, FL 33014 PMA NumberP120002 Supplement NumberS020 Date Received09/01/2021 Decision Date02/25/2022 Product Code NIP Advisory Committee Cardiovascular Clinical TrialsNCT00739102 Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement for A New Delivery System To Allow Use With A Transradial Approach. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120002 | Original Filing | |
| S022 | 2022-11-07 | 30-day Notice |
| S021 | ||
| S020 | 2021-09-01 | Normal 180 Day Track |
| S019 | 2021-03-03 | 30-day Notice |
| S018 | 2020-09-25 | 30-day Notice |
| S017 | 2020-05-01 | 30-day Notice |
| S016 | 2019-05-24 | 30-day Notice |
| S015 | 2019-04-01 | 30-day Notice |
| S014 | 2018-12-03 | 30-day Notice |
| S013 | 2018-02-26 | 30-day Notice |
| S012 | 2016-03-21 | 30-day Notice |
| S011 | 2015-10-05 | 30-day Notice |
| S010 | 2015-05-01 | 30-day Notice |
| S009 | 2015-03-19 | 135 Review Track For 30-day Notice |
| S008 | 2015-03-18 | 30-day Notice |
| S007 | 2015-03-11 | Normal 180 Day Track No User Fee |
| S006 | 2014-12-19 | Normal 180 Day Track No User Fee |
| S005 | 2014-09-23 | 30-day Notice |
| S004 | 2014-05-12 | 30-day Notice |
| S003 | 2014-04-16 | 30-day Notice |
| S002 | ||
| S001 | 2014-03-24 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 20705032082362 | P120002 | 000 |
| 20705032082430 | P120002 | 000 |
| 20705032082539 | P120002 | 000 |
| 20705032082614 | P120002 | 000 |
| 20705032082638 | P120002 | 000 |
| 20705032082645 | P120002 | 000 |
| 20705032082652 | P120002 | 000 |
| 20705032082683 | P120002 | 000 |
| 20705032024478 | P120002 | 000 |
| 20705032024997 | P120002 | 000 |
| 20705032025017 | P120002 | 000 |
| 20705032025031 | P120002 | 000 |
| 20705032025055 | P120002 | 000 |
| 20705032063385 | P120002 | 004 |
| 20705032063392 | P120002 | 004 |
| 20705032063408 | P120002 | 004 |
| 20705032063415 | P120002 | 004 |
| 20705032063422 | P120002 | 004 |
| 20705032063439 | P120002 | 004 |