| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S027) | Edwards Lifesciences, LLC | 2022-09-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultr (P140031/S144) | Edwards Lifesciences, LLC | 2022-09-23 |
| PASCAL Precision Transcatheter Valve Repair System (P220003) | Edwards Lifesciences, LLC | 2022-09-14 |
| Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S208) | Edwards Lifesciences, LLC | 2022-09-12 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S067) | Edwards Lifesciences, LLC | 2022-09-12 |
| Edwards INTUITY Elite Valve System (P150036/S063) | Edwards Lifesciences, LLC | 2022-09-12 |
| Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi (P150048/S065) | Edwards Lifesciences, LLC | 2022-09-08 |
| Edwards Alterra Adaptive Prestent System (P200015/S020) | Edwards Lifesciences, LLC | 2022-08-08 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve (P150048/S066) | Edwards Lifesciences, LLC | 2022-08-01 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S141) | Edwards Lifesciences, LLC | 2022-07-28 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S023) | Edwards Lifesciences, LLC | 2022-07-25 |
| Edwards Alterra Adaptive Prestent System (P200015/S022) | Edwards Lifesciences, LLC | 2022-07-06 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S021) | Edwards Lifesciences, LLC | 2022-06-23 |
| Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi (P150048/S064) | Edwards Lifesciences, LLC | 2022-04-26 |
| Edwards INTUITY ELITE Delivery System (P150036/S062) | Edwards Lifesciences, LLC | 2022-04-20 |
| Edwards Alterra Adaptive Prestent System (P200015/S019) | Edwards Lifesciences, LLC | 2022-04-08 |
| KONECT RESILIA Aortic Valved Conduit (P150048/S063) | Edwards Lifesciences, LLC | 2022-04-08 |
| EDWARDS INTUITY Elite Valve (P150036/S060) | Edwards Lifesciences, LLC | 2022-03-31 |
| Carpentier-Edwards PERIMOUNT Magna Ease® Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S206) | Edwards Lifesciences, LLC | 2022-03-31 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis (P150048/S061) | Edwards Lifesciences, LLC | 2022-03-31 |
| MITRIS RESILIA Mitral Valve (P150048/S047) | Edwards Lifesciences, LLC | 2022-03-16 |
| Edwards INTUITY Elite Valve, Edwards INTUITY Elite Valve Delivery System (P150036/S057) | Edwards Lifesciences, LLC | 2022-03-11 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S056) | Edwards Lifesciences, LLC | 2022-02-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S139) | Edwards Lifesciences, LLC | 2022-01-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P200015/S017) | Edwards Lifesciences, LLC | 2022-01-23 |
| 9600CR Crimper (P140031/S138) | Edwards Lifesciences, LLC | 2022-01-04 |
| 9600CR Crimper (P200015/S016) | Edwards Lifesciences, LLC | 2022-01-04 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S011) | Edwards Lifesciences, LLC | 2021-12-16 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprostheses (P860057/S202) | Edwards Lifesciences, LLC | 2021-12-13 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS (P150048/S059) | Edwards Lifesciences, LLC | 2021-11-18 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S015) | Edwards Lifesciences, LLC | 2021-11-18 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S205) | Edwards Lifesciences, LLC | 2021-11-18 |
| EDWARDS INTUITY Elite Valve System (P150036/S059) | Edwards Lifesciences, LLC | 2021-11-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S137) | Edwards Lifesciences, LLC | 2021-11-18 |
| Edwards SAPIEN 3 transcatheter heart valve (P140031/S136) | Edwards Lifesciences, LLC | 2021-10-28 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S014) | Edwards Lifesciences, LLC | 2021-10-28 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr (P860057/S204) | Edwards Lifesciences, LLC | 2021-10-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart Valve. (P140031/S135) | Edwards Lifesciences, LLC | 2021-10-12 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis, and t (P150048/S058) | Edwards Lifesciences, LLC | 2021-10-12 |
| Edwards INTUITY Elite Valve (P150036/S058) | Edwards Lifesciences, LLC | 2021-10-12 |
| 9600TFX Edwards SAPIEN 3 Transcatheter Heart Valves, 9750TFX Edwards SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S134) | Edwards Lifesciences, LLC | 2021-09-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System,9600TFXEdwards SAPIEN 3 Transca (P200015/S013) | Edwards Lifesciences, LLC | 2021-09-22 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems (P140031/S130) | Edwards Lifesciences, LLC | 2021-09-17 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar (P860057/S203) | Edwards Lifesciences, LLC | 2021-09-08 |
| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S057) | Edwards Lifesciences, LLC | 2021-09-08 |
| Edwards INTUITY Elite Valve (P150036/S056) | Edwards Lifesciences, LLC | 2021-09-08 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S132) | Edwards Lifesciences, LLC | 2021-09-03 |
| EDWARDS INTUITY Elite Aortic Valve (P150036/S055) | Edwards Lifesciences, LLC | 2021-08-31 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories (P140031/S133) | Edwards Lifesciences, LLC | 2021-08-31 |
| SAPIEN 3 Transcatheter Heart Valve and Accesssories (P200015/S012) | Edwards Lifesciences, LLC | 2021-08-31 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S131) | Edwards Lifesciences, LLC | 2021-08-12 |
| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S055) | Edwards Lifesciences, LLC | 2021-07-23 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S129) | Edwards Lifesciences, LLC | 2021-07-22 |
| Edwards Commander Delivery System, Crimper (P200015/S010) | Edwards Lifesciences, LLC | 2021-06-29 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S054) | Edwards Lifesciences, LLC | 2021-06-02 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S125) | Edwards Lifesciences, LLC | 2021-05-13 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S009) | Edwards Lifesciences, LLC | 2021-04-16 |
| RESILIA Solutions System (P150048/S053) | Edwards Lifesciences, LLC | 2021-04-15 |
| SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S128) | Edwards Lifesciences, LLC | 2021-03-31 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S052) | Edwards Lifesciences, LLC | 2021-03-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S127) | Edwards Lifesciences, LLC | 2021-03-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S008) | Edwards Lifesciences, LLC | 2021-03-19 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S113) | Edwards Lifesciences, LLC | 2021-03-19 |
| SAPIEN 3 Transcatheter Heart Valve System (P200015/S005) | Edwards Lifesciences, LLC | 2021-02-17 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S126) | Edwards Lifesciences, LLC | 2021-02-17 |
| SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S099) | Edwards Lifesciences, LLC | 2021-01-27 |
| Edwards Commander Delivery System (P200015/S007) | Edwards Lifesciences, LLC | 2020-12-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories, Pulmonic Indication (P200015/S003) | Edwards Lifesciences, LLC | 2020-12-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S124) | Edwards Lifesciences, LLC | 2020-12-16 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S123) | Edwards Lifesciences, LLC | 2020-12-13 |
| EDWARDS INTUITY Elite Valve (P150036/S054) | Edwards Lifesciences, LLC | 2020-12-13 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve (P150048/S051) | Edwards Lifesciences, LLC | 2020-12-13 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S201) | Edwards Lifesciences, LLC | 2020-12-13 |
| Edwards Commander Delivery System (P200015/S006) | Edwards Lifesciences, LLC | 2020-12-10 |
| EDWARDS INTUITY Elite Valve (P150036/S053) | Edwards Lifesciences, LLC | 2020-11-10 |
| PERIMOUNT Bioprosthesis, PERIMOUNT Magna Aortic Bioprosthesis, PERIMOUNT Magna Ease Bioprosthesis, PERIMOUNT Plus Biopro (P860057/S200) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S112) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (Pulmonic) (P200015/S001) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S121) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis (P150048/S050) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards Commander Delivery System (P200015/S002) | Edwards Lifesciences, LLC | 2020-11-05 |
| Edwards Commander Delivery System (P140031/S122) | Edwards Lifesciences, LLC | 2020-11-05 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv (P150048/S049) | Edwards Lifesciences, LLC | 2020-10-28 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S109) | Edwards Lifesciences, LLC | 2020-10-27 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S116) | Edwards Lifesciences, LLC | 2020-10-27 |
| Edwards Commander Delivery System (P140031/S120) | Edwards Lifesciences, LLC | 2020-10-05 |
| Edwards Commander Delivery System (P140031/S119) | Edwards Lifesciences, LLC | 2020-09-25 |
| Edwards Commander Delivery System (P200015/S004) | Edwards Lifesciences, LLC | 2020-09-25 |
| EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S112) | Edwards Lifesciences, LLC | 2020-09-09 |
| Ascendra+ Delivery System, NovaFlex+ Delivery System (P130009/S111) | Edwards Lifesciences, LLC | 2020-09-07 |
| Commander Delivery System, Certitude Delivery System (P140031/S118) | Edwards Lifesciences, LLC | 2020-09-07 |
| EDWARDS INTUITY Elite Delivery System (P150036/S052) | Edwards Lifesciences, LLC | 2020-09-07 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv (P150048/S048) | Edwards Lifesciences, LLC | 2020-09-07 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015) | Edwards Lifesciences, LLC | 2020-08-31 |
| Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valves (P140031/S107) | Edwards Lifesciences, LLC | 2020-07-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S117) | Edwards Lifesciences, LLC | 2020-07-22 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S046) | Edwards Lifesciences, LLC | 2020-07-22 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S110) | Edwards Lifesciences, LLC | 2020-07-22 |
| KONECT RESILIA Aortic Valved Conduit AVC (P150048/S029) | Edwards Lifesciences, LLC | 2020-07-10 |
| Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve (P860057/S197) | Edwards Lifesciences, LLC | 2020-06-23 |