Approval for the updated final labeling to reflect the 5-year data obtained in the pzf shield pas study.
| Device | COBRA PzF NanoCoated Coronary Stent System |
| Generic Name | Stent, Coronary |
| Applicant | CELONOVA BIOSCIENCES, INC. |
| Date Received | 2021-05-20 |
| Decision Date | 2021-10-12 |
| PMA | P160014 |
| Supplement | S018 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CELONOVA BIOSCIENCES, INC. 8023 Vantage Drive, Suite 1500 san Antonio, TX 78230 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160014 | | Original Filing |
| S018 |
2021-05-20 |
Normal 180 Day Track No User Fee |
| S017 |
2020-10-20 |
30-day Notice |
| S016 |
2020-04-21 |
30-day Notice |
| S015 | | |
| S014 |
2019-09-12 |
30-day Notice |
| S013 | | |
| S012 | | |
| S011 | | |
| S010 | | |
| S009 | | |
| S008 |
2019-02-22 |
30-day Notice |
| S007 |
2019-02-15 |
30-day Notice |
| S006 |
2018-10-23 |
135 Review Track For 30-day Notice |
| S005 |
2018-10-19 |
Real-time Process |
| S004 |
2018-09-04 |
30-day Notice |
| S003 |
2018-08-16 |
Real-time Process |
| S002 |
2018-06-12 |
30-day Notice |
| S001 |
2018-03-19 |
30-day Notice |
NIH GUDID Devices