This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the cobra pzf nanocoated coronary stent system is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to do novo lesions in native coronary arteries. The cobra pzf stent system is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (ptca) with a reference vessel diameter of 2. 5-4. 0 mm and lesion length of
| Device | COBRA PzF NanoCoated Coronary Stent System |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | CELONOVA BIOSCIENCES, INC. |
| Date Received | 2016-05-02 |
| Decision Date | 2017-02-21 |
| Notice Date | 2017-02-17 |
| PMA | P160014 |
| Supplement | S |
| Product Code | MAF |
| Docket Number | 17M-1122 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CELONOVA BIOSCIENCES, INC. 8023 Vantage Drive, Suite 1500 san Antonio, TX 78230 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00879397000944 | P160014 | 000 |
| 00879397000784 | P160014 | 000 |
| 00879397000777 | P160014 | 000 |
| 00879397000760 | P160014 | 000 |
| 00879397000753 | P160014 | 000 |
| 00879397000746 | P160014 | 000 |
| 00879397000739 | P160014 | 000 |
| 00879397000722 | P160014 | 000 |
| 00879397000715 | P160014 | 000 |
| 00879397000708 | P160014 | 000 |
| 00879397000692 | P160014 | 000 |
| 00879397000685 | P160014 | 000 |
| 00879397000678 | P160014 | 000 |
| 00879397000661 | P160014 | 000 |
| 00879397000791 | P160014 | 000 |
| 00879397000807 | P160014 | 000 |
| 00879397000937 | P160014 | 000 |
| 00879397000920 | P160014 | 000 |
| 00879397000913 | P160014 | 000 |
| 00879397000906 | P160014 | 000 |
| 00879397000890 | P160014 | 000 |
| 00879397000883 | P160014 | 000 |
| 00879397000876 | P160014 | 000 |
| 00879397000869 | P160014 | 000 |
| 00879397000852 | P160014 | 000 |
| 00879397000845 | P160014 | 000 |
| 00879397000838 | P160014 | 000 |
| 00879397000821 | P160014 | 000 |
| 00879397000814 | P160014 | 000 |
| 00879397000654 | P160014 | 000 |