|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
INTUITY Delivery System - Accessories
|
EDWARDS LIFESCIENCES, LLC. |
P150036 S067 |
02/14/2023 |
Perceval S Sutureless Heart Valve; Perceval Plus S...
|
CORCYM Canada Corp. |
P150011 S027 |
03/02/2023 |
Epic™ Max Tissue Heart Valves
|
Abbott Medical |
P040021 S052 |
03/28/2023 |
EDWARDS INTUITY Elite Valve System
|
EDWARDS LIFESCIENCES, LLC. |
P150036 S069 |
04/27/2023 |
Edwards Pericardial Aortic Bioprosthesis, Edwards ...
|
EDWARDS LIFESCIENCES, LLC. |
P150048 S071 |
04/27/2023 |
EDWARDS INTUITY Elite Valve System, Delivery Syste...
|
EDWARDS LIFESCIENCES, LLC. |
P150036 S068 |
05/04/2023 |
KONECT RESILIA Aortic Valved Conduit
|
EDWARDS LIFESCIENCES, LLC. |
P150048 S072 |
07/12/2023 |
INSPIRIS RESILIA Aortic Valve, Model 11500A
|
EDWARDS LIFESCIENCES, LLC. |
P150048 S073 |
07/27/2023 |
Avalus Bioprosthesis
|
Medtronic Inc. |
P170006 S022 |
08/10/2023 |
Hancock II Bioprosthesis
|
Medtronic, Inc. |
P970031 S070 |
08/10/2023 |