Approval for changes to the rinsing and fixations solutions used inthe manufacture of the device. The device, as modified, will be marketed under the trade name 3f aortic bioprosthesis, model 1000 and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
| Device | 3F AORTIC BIOPROSTHESIS |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2013-02-22 |
| Decision Date | 2013-05-29 |
| PMA | P060025 |
| Supplement | S010 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| 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