| Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV (P140031/S170) | Edwards Lifesciences, LLC | 2024-02-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV (P200015/S052) | Edwards Lifesciences, LLC | 2024-02-14 |
| INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC) (P150048/S078) | Edwards Lifesciences, LLC | 2024-02-13 |
| Edwards INTUITY Elite Valve System (P150036/S073) | Edwards Lifesciences, LLC | 2024-02-13 |
| Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S216) | Edwards Lifesciences, LLC | 2024-02-13 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013) | Edwards Lifesciences, LLC | 2024-02-01 |
| INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve (P150048/S077) | Edwards Lifesciences, LLC | 2024-01-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S051) | Edwards Lifesciences, LLC | 2023-12-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S169) | Edwards Lifesciences, LLC | 2023-12-14 |
| EDWARDS INTUITY Elite Valve (P150036/S071) | Edwards Lifesciences, LLC | 2023-12-11 |
| Carpentier-Edwards PERIMOUNT Aortic and Mitral Surgical Heart Valves (P860057/S214) | Edwards Lifesciences, LLC | 2023-12-11 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S167) | Edwards Lifesciences, LLC | 2023-12-11 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S049) | Edwards Lifesciences, LLC | 2023-12-11 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr (P860057/S215) | Edwards Lifesciences, LLC | 2023-12-06 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S168) | Edwards Lifesciences, LLC | 2023-12-06 |
| EDWARDS INTUITY Elite Valve (P150036/S072) | Edwards Lifesciences, LLC | 2023-12-06 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S076) | Edwards Lifesciences, LLC | 2023-12-06 |
| Edwards SAPIEN 3 Transcatheter Heart Valve for Pulmonic Indication (P200015/S050) | Edwards Lifesciences, LLC | 2023-12-06 |
| Edwards Commander Delivery System (P140031/S166) | Edwards Lifesciences, LLC | 2023-11-20 |
| Edwards Commander Delivery System (P200015/S048) | Edwards Lifesciences, LLC | 2023-11-20 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S014) | Edwards Lifesciences, LLC | 2023-11-13 |
| INSPIRIS RESILIA Aortic Valve (P150048/S075) | Edwards Lifesciences, LLC | 2023-10-31 |
| Edwards Commander Delivery System (P140031/S165) | Edwards Lifesciences, LLC | 2023-10-30 |
| Edwards Commander Delivery System (P200015/S047) | Edwards Lifesciences, LLC | 2023-10-30 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S013) | Edwards Lifesciences, LLC | 2023-10-18 |
| SAPIEN 3 Pulmonic Delivery System (P200015/S046) | Edwards Lifesciences, LLC | 2023-09-25 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S164) | Edwards Lifesciences, LLC | 2023-09-12 |
| Edwards Crimper 9600CR (P140031/S163) | Edwards Lifesciences, LLC | 2023-08-25 |
| Edwards Crimper 9600CR (P200015/S045) | Edwards Lifesciences, LLC | 2023-08-25 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra (P200015/S044) | Edwards Lifesciences, LLC | 2023-08-22 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S213) | Edwards Lifesciences, LLC | 2023-08-22 |
| EDWARDS INTUITY Elite Valve System (P150036/S070) | Edwards Lifesciences, LLC | 2023-08-22 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S074) | Edwards Lifesciences, LLC | 2023-08-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra (P140031/S161) | Edwards Lifesciences, LLC | 2023-08-22 |
| Edwards Commander Delivery System (P200015/S043) | Edwards Lifesciences, LLC | 2023-08-05 |
| Edwards Commander Delivery System (P140031/S160) | Edwards Lifesciences, LLC | 2023-08-05 |
| INSPIRIS RESILIA Aortic Valve, Model 11500A (P150048/S073) | Edwards Lifesciences, LLC | 2023-07-27 |
| KONECT RESILIA Aortic Valved Conduit (P150048/S072) | Edwards Lifesciences, LLC | 2023-07-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra R (P140031/S159) | Edwards Lifesciences, LLC | 2023-07-06 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S007) | Edwards Lifesciences, LLC | 2023-07-06 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P200015/S042) | Edwards Lifesciences, LLC | 2023-07-06 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S012) | Edwards Lifesciences, LLC | 2023-06-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S041) | Edwards Lifesciences, LLC | 2023-06-13 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S158) | Edwards Lifesciences, LLC | 2023-06-13 |
| Edwards Commander delivery system (Size 29mm) (P200015/S040) | Edwards Lifesciences, LLC | 2023-06-02 |
| Edwards Commander delivery system (Size 29mm) (P140031/S157) | Edwards Lifesciences, LLC | 2023-06-02 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S011) | Edwards Lifesciences, LLC | 2023-06-01 |
| PASCAL Precision Transcatheter Valve Repair System (Implant System), PASCAL Precision Transcatheter Valve Repair System (P220003/S009) | Edwards Lifesciences, LLC | 2023-05-31 |
| PASCAL Precision Transcatheter Valve Repair System (Guide Sheath), PASCAL Precision Transcatheter Valve Repair System (I (P220003/S010) | Edwards Lifesciences, LLC | 2023-05-30 |
| SAPIEN 3 Pulmonic Delivery System (S3 PDS) (P200015/S039) | Edwards Lifesciences, LLC | 2023-05-30 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S156) | Edwards Lifesciences, LLC | 2023-05-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S038) | Edwards Lifesciences, LLC | 2023-05-18 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S008) | Edwards Lifesciences, LLC | 2023-05-11 |
| EDWARDS INTUITY Elite Valve System, Delivery System (P150036/S068) | Edwards Lifesciences, LLC | 2023-05-04 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS (P150048/S071) | Edwards Lifesciences, LLC | 2023-04-27 |
| EDWARDS INTUITY Elite Valve System (P150036/S069) | Edwards Lifesciences, LLC | 2023-04-27 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar (P860057/S212) | Edwards Lifesciences, LLC | 2023-04-27 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S155) | Edwards Lifesciences, LLC | 2023-04-26 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S037) | Edwards Lifesciences, LLC | 2023-04-26 |
| Edwards Commander Delivery System (P200015/S029) | Edwards Lifesciences, LLC | 2023-04-04 |
| Edwards Commander Delivery System (P140031/S146) | Edwards Lifesciences, LLC | 2023-04-04 |
| Edwards Commander Delivery System (P140031/S154) | Edwards Lifesciences, LLC | 2023-03-30 |
| Edwards Commander Delivery System (P200015/S036) | Edwards Lifesciences, LLC | 2023-03-30 |
| Edwards Commander Delivery System (P140031/S153) | Edwards Lifesciences, LLC | 2023-03-22 |
| Edwards Commander Delivery System (P200015/S035) | Edwards Lifesciences, LLC | 2023-03-22 |
| Edwards Commander Delivery System (P140031/S143) | Edwards Lifesciences, LLC | 2023-03-09 |
| Edwards Commander Delivery System (P200015/S026) | Edwards Lifesciences, LLC | 2023-03-09 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S152) | Edwards Lifesciences, LLC | 2023-03-08 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S034) | Edwards Lifesciences, LLC | 2023-03-03 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S006) | Edwards Lifesciences, LLC | 2023-03-03 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S033) | Edwards Lifesciences, LLC | 2023-02-22 |
| INTUITY Delivery System - Accessories (P150036/S067) | Edwards Lifesciences, LLC | 2023-02-14 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S151) | Edwards Lifesciences, LLC | 2023-01-20 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S028) | Edwards Lifesciences, LLC | 2023-01-19 |
| Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S060) | Edwards Lifesciences, LLC | 2022-12-29 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S005) | Edwards Lifesciences, LLC | 2022-12-20 |
| Crimper (P140031/S150) | Edwards Lifesciences, LLC | 2022-12-12 |
| Crimper (P200015/S032) | Edwards Lifesciences, LLC | 2022-12-12 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S004) | Edwards Lifesciences, LLC | 2022-12-07 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S003) | Edwards Lifesciences, LLC | 2022-12-07 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S002) | Edwards Lifesciences, LLC | 2022-11-20 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories (P200015/S031) | Edwards Lifesciences, LLC | 2022-11-16 |
| Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses (P860057/S207) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S018) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S062) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S140) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards INTUITY Elite Valve System (P150036/S061) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories (P140031/S149) | Edwards Lifesciences, LLC | 2022-11-16 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S024) | Edwards Lifesciences, LLC | 2022-10-28 |
| Edwards Certitude Introducer Sheath Set (P140031/S147) | Edwards Lifesciences, LLC | 2022-10-26 |
| Edwards Commander Delivery System (P200015/S030) | Edwards Lifesciences, LLC | 2022-10-24 |
| Edwards Commander Delivery System (P140031/S148) | Edwards Lifesciences, LLC | 2022-10-24 |
| EDWARDS INTUITY Elite Valve System (P150036/S065) | Edwards Lifesciences, LLC | 2022-10-19 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S210) | Edwards Lifesciences, LLC | 2022-10-19 |
| PASCAL Precision Implant System (PASCAL Implant, 10mm), PASCAL Precision Implant System (PASCAL Ace Implant, 5mm) (P220003/S001) | Edwards Lifesciences, LLC | 2022-10-19 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S069) | Edwards Lifesciences, LLC | 2022-10-19 |
| SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System (P140031/S145) | Edwards Lifesciences, LLC | 2022-09-23 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesi (P150048/S068) | Edwards Lifesciences, LLC | 2022-09-23 |
| EDWARDS INTUITY Elite Valve System (P150036/S064) | Edwards Lifesciences, LLC | 2022-09-23 |
| Carpentier-Edwards® PERIMOUNT ®Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic (P860057/S209) | Edwards Lifesciences, LLC | 2022-09-23 |