Approval for removal of perfluoro-octanoic acid (pfoa) from the polytetrafluoro-ethylene (ptfe) tubing.
| Device | S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | CORDIS CORP. |
| Date Received | 2015-03-19 |
| Decision Date | 2015-11-25 |
| PMA | P120002 |
| Supplement | S009 |
| Product Code | NIP |
| 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 | CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555 |
Supplemental Filings
| 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 |
NIH GUDID Devices