|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
EDWARDS SAPIEN XT TRANSCATHETER HEART VAlVE
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S066 |
05/01/2017 |
Edwards SAPIEN XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S068 |
04/03/2017 |
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S069 |
01/19/2017 |
SAPIEN XT Transcatheter Heart Valve (Frame only) A...
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S070 |
03/09/2017 |
Edwards SAPIEN XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S071 |
04/07/2017 |
NovaFlex+ Delivery System
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S072 |
04/20/2017 |
Edwards SAPIEN XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S073 |
05/10/2017 |
Edwards SAPIEN XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S074 |
05/23/2017 |
Sapien XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S076 |
06/20/2017 |
Sapien XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S077 |
06/22/2017 |