Approval for the ats 3f aortic bioprosthesis, model 1000 (sizes 21, 23, 25, 27 and 29 mm). The device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
| Device | ATS 3F AORTIC BIOPROSTHESIS |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2006-09-27 |
| Decision Date | 2008-10-30 |
| Notice Date | 2008-11-14 |
| PMA | P060025 |
| Supplement | S |
| Product Code | LWR |
| Docket Number | 08M-0594 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 710 Medtronic Parkway Ne minneapolis, MN 55432 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060025 | | Original Filing |
| S014 |
2015-02-09 |
Normal 180 Day Track No User Fee |
| S013 |
2013-10-31 |
Normal 180 Day Track No User Fee |
| S012 |
2013-07-09 |
Real-time Process |
| S011 |
2013-03-05 |
Special (immediate Track) |
| S010 |
2013-02-22 |
Real-time Process |
| S009 |
2012-04-30 |
Normal 180 Day Track No User Fee |
| S008 |
2011-11-23 |
30-day Notice |
| S007 |
2010-09-17 |
30-day Notice |
| S006 |
2010-05-21 |
Special (immediate Track) |
| S005 |
2010-05-14 |
Normal 180 Day Track No User Fee |
| S004 |
2009-02-09 |
30-day Notice |
| S003 |
2009-01-05 |
Real-time Process |
| S002 | | |
| S001 |
2008-10-31 |
30-day Notice |
NIH GUDID Devices