Approval for extension of the shelf-life of the ats 3f aortic bioprosthesis, model 1000 valves (sizes 19, 21, 23, 25, 27 and 29 mm) from 2 years to 5 years. The device is indicated for ¿.. Use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their valve with a prosthetic device. The usual conditions of advanced disease include aortic stenosis, aortic incompetence, and a combination of the two. ¿
| Device | ATS 3F AORTIC BIOPROSTHESIS MODEL 1000 |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2009-01-05 |
| Decision Date | 2009-03-05 |
| PMA | P060025 |
| Supplement | S003 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 710 Medtronic Parkway Ne minneapolis, MN 55432 |
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