|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
SAPIEN 3 Ultra transcatheter heart valve
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S085 |
08/16/2019 |
SAPIEN 3 Transcatheter Heart Valve and Accessories
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S090 |
08/15/2019 |
SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Va...
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S087 |
07/29/2019 |
Edwards Sapien 3 Transcatheter Heart Valve and Sap...
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S089 |
06/11/2019 |
SAPIEN 3 Ultra Transcatheter Heart Valve System
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S088 |
06/04/2019 |
Edwards SAPIEN 3 (XT) Transcatheter Heart Valves
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S097 |
03/19/2019 |
Edwards SAPIEN 3, SAPIEN 3 Ultra Transcatheter Hea...
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S082 |
03/19/2019 |
Edwards SAPIEN 3 Transcatheter Heart Valves
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S083 |
03/19/2019 |
Edwards SAPIEN 3 Transcatheter Heart Valve and Acc...
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S084 |
03/13/2019 |
Edwards SAPIEN XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S096 |
03/03/2019 |