|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
MEDTRONIC COREVALVE(TM) EVOLUT(TM) R SYSTEM
|
Medtronic, Inc. |
P130021 S028 |
04/11/2017 |
Edwards SAPIEN XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S071 |
04/07/2017 |
Edwards SAPIEN 3 Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S036 |
04/07/2017 |
EnVeo R Delivery Catheter System
|
Medtronic, Inc. |
P130021 S035 |
04/05/2017 |
En Veo R DCS and En Veo R LS
|
Medtronic, Inc. |
P130021 S032 |
04/04/2017 |
Edwards SAPIEN XT Transcatheter Heart Valve
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S068 |
04/03/2017 |
Sapien 3 Transcatheter Heart Valve and Accessories
|
EDWARDS LIFESCIENCES, LLC. |
P140031 S033 |
04/03/2017 |
Medtronic CoreValve Evolut PRO System
|
Medtronic, Inc. |
P130021 S029 |
03/20/2017 |
SAPIEN XT Transcatheter Heart Valve (Frame only) A...
|
EDWARDS LIFESCIENCES, LLC. |
P130009 S070 |
03/09/2017 |
Medtronic CoreValve System/Medtronic Evolut R Syst...
|
Medtronic, Inc. |
P130021 S030 |
03/09/2017 |