|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
Epic Plus and Epic Plus Supra
|
Abbott Medical |
P040021 S056 |
01/23/2024 |
Edwards INTUITY Elite Valve System
|
EDWARDS LIFESCIENCES, LLC. |
P150036 S073 |
02/13/2024 |
EDWARDS INTUITY Elite Valve System
|
EDWARDS LIFESCIENCES, LLC. |
P150036 S074 |
03/25/2024 |
EDWARDS INTUITY Elite Valve System
|
EDWARDS LIFESCIENCES, LLC. |
P150036 S075 |
05/23/2024 |
INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aort...
|
EDWARDS LIFESCIENCES, LLC. |
P150048 S077 |
01/16/2024 |
INSPIRIS™ RESILIA™ Aortic Valve, KONECT RESILIA Ao...
|
EDWARDS LIFESCIENCES, LLC. |
P150048 S078 |
02/13/2024 |
MITRIS RESILIA Mitral Valve
|
EDWARDS LIFESCIENCES, LLC. |
P150048 S079 |
03/01/2024 |
Edwards Pericardial Aortic Bioprosthesis, Edwards ...
|
EDWARDS LIFESCIENCES, LLC. |
P150048 S080 |
05/23/2024 |
Avalus Bioprosthesis
|
Medtronic Inc. |
P170006 S024 |
01/08/2024 |
Avalus Ultra Bioprosthesis
|
Medtronic Inc. |
P170006 S025 |
01/31/2024 |