Approval for the avalus bioprosthesis, model 400. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
| Device | AVALUS(TM) BIOPROSTHESIS |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | Medtronic Inc. |
| Date Received | 2017-02-02 |
| Decision Date | 2017-07-31 |
| Notice Date | 2017-08-08 |
| PMA | P170006 |
| Supplement | S |
| Product Code | LWR |
| Docket Number | 17M-4756 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Inc. 1851 E. Deere Avenue santa Ana, CA 92705 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170006 | | Original Filing |
| S021 |
2022-07-20 |
30-day Notice |
| S020 |
2022-02-28 |
30-day Notice |
| S019 |
2020-11-25 |
30-day Notice |
| S018 |
2020-10-02 |
Real-time Process |
| S017 |
2020-08-03 |
30-day Notice |
| S016 |
2019-09-26 |
Real-time Process |
| S015 |
2019-06-20 |
30-day Notice |
| S014 |
2019-05-31 |
30-day Notice |
| S013 | | |
| S012 |
2019-05-03 |
30-day Notice |
| S011 |
2019-04-18 |
30-day Notice |
| S010 |
2019-01-29 |
30-day Notice |
| S009 |
2019-01-24 |
30-day Notice |
| S008 |
2018-11-21 |
30-day Notice |
| S007 | | |
| S006 |
2018-07-27 |
30-day Notice |
| S005 |
2017-11-22 |
30-day Notice |
| S004 |
2017-10-23 |
30-day Notice |
| S003 |
2017-10-18 |
30-day Notice |
| S002 | | |
| S001 |
2017-09-11 |
30-day Notice |
NIH GUDID Devices