| Edwards Commander Delivery System (P140031/S115) | Edwards Lifesciences, LLC | 2020-05-21 |
| SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S114) | Edwards Lifesciences, LLC | 2020-04-29 |
| Edwards Commander Delivery System, Edwards Certitude Delivery System (P140031/S113) | Edwards Lifesciences, LLC | 2020-04-17 |
| Edwards INTUITY Elite Tube Extrusion (P150036/S051) | Edwards Lifesciences, LLC | 2020-04-14 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve (P150048/S043) | Edwards Lifesciences, LLC | 2020-04-10 |
| EDWARDS INTUITY Elite Valve (P150036/S048) | Edwards Lifesciences, LLC | 2020-04-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S105) | Edwards Lifesciences, LLC | 2020-04-10 |
| Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther (P860057/S196) | Edwards Lifesciences, LLC | 2020-04-10 |
| Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valve (P140031/S102) | Edwards Lifesciences, LLC | 2020-04-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S111) | Edwards Lifesciences, LLC | 2020-04-01 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S110) | Edwards Lifesciences, LLC | 2020-03-11 |
| EDWARDS INTUITY Elite Valve System (P150036/S050) | Edwards Lifesciences, LLC | 2020-03-11 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process, Carpentier-Edward (P860057/S199) | Edwards Lifesciences, LLC | 2020-03-11 |
| Sapien 3 Ultra Transcatheter Heart Valve with the Commander Delivery System (P140031/S104) | Edwards Lifesciences, LLC | 2020-03-10 |
| EDWARDS INTUITY Elite Aortic Valve (P150036/S049) | Edwards Lifesciences, LLC | 2020-03-05 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S108) | Edwards Lifesciences, LLC | 2020-03-05 |
| Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE (P860057/S198) | Edwards Lifesciences, LLC | 2020-03-05 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V (P150048/S044) | Edwards Lifesciences, LLC | 2020-03-05 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S109) | Edwards Lifesciences, LLC | 2020-03-05 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S108) | Edwards Lifesciences, LLC | 2020-03-05 |
| SAPIEN 3 Ultra Transcatheter Heart Valve System (THV) (P140031/S105) | Edwards Lifesciences, LLC | 2020-01-16 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S189) | Edwards Lifesciences, LLC | 2020-01-15 |
| EDWARDS INTUITY Elite Valve (P150036/S039) | Edwards Lifesciences, LLC | 2020-01-15 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S034) | Edwards Lifesciences, LLC | 2020-01-15 |
| Carpentier-Edwards Perimount Aortic Bioprostheses and Carpentier-Edwards Perimount Mitral Bioprostheses (P860057/S195) | Edwards Lifesciences, LLC | 2019-11-26 |
| Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve (P150048/S042) | Edwards Lifesciences, LLC | 2019-11-26 |
| Edwards Intuity Valves and Delivery Systems (P150036/S047) | Edwards Lifesciences, LLC | 2019-11-26 |
| Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra Transcatheter Heart Valve, Commander Delivery System, Edwards eSheath (P140031/S101) | Edwards Lifesciences, LLC | 2019-11-26 |
| Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial (P860057/S194) | Edwards Lifesciences, LLC | 2019-11-24 |
| Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve (P150048/S041) | Edwards Lifesciences, LLC | 2019-11-24 |
| Edwards Intuity Elite Valve System (P150036/S045) | Edwards Lifesciences, LLC | 2019-11-24 |
| Sapien XT Transcatheter Heart Valve (P130009/S104) | Edwards Lifesciences, LLC | 2019-11-24 |
| Sapien 3 Transcatheter Heart Valve and Ultra Transcatheter Heart Valve (P140031/S100) | Edwards Lifesciences, LLC | 2019-11-24 |
| Edwards Intuity Elite Valve System (P150036/S044) | Edwards Lifesciences, LLC | 2019-11-18 |
| Edwards Inspiris Resilia Aortic Valve (P150048/S040) | Edwards Lifesciences, LLC | 2019-11-18 |
| Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial (P860057/S193) | Edwards Lifesciences, LLC | 2019-11-18 |
| Edwards Intuity Elite Delivery System (P150036/S046) | Edwards Lifesciences, LLC | 2019-11-14 |
| Edwards Intuity Elite Valve System (P150036/S042) | Edwards Lifesciences, LLC | 2019-11-07 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S101) | Edwards Lifesciences, LLC | 2019-11-04 |
| Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis (P150048/S039) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S103) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Intuity Elite Valve (P150036/S043) | Edwards Lifesciences, LLC | 2019-10-28 |
| Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi (P860057/S192) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Sapien 3 Transcatheter Heart Valve and Edward Sapien 3 Ultra Transcatheter Heart Valve (P140031/S098) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Expandable Introducer Sheath Set (P130009/S102) | Edwards Lifesciences, LLC | 2019-10-17 |
| Edwards eSheath Introducer Set (P140031/S097) | Edwards Lifesciences, LLC | 2019-10-17 |
| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S038) | Edwards Lifesciences, LLC | 2019-10-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S096) | Edwards Lifesciences, LLC | 2019-10-03 |
| Edwards Sapien 3 Ultra Delivery System and Edwards Commander Delivery System (P140031/S095) | Edwards Lifesciences, LLC | 2019-09-30 |
| Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER (P860057/S191) | Edwards Lifesciences, LLC | 2019-09-24 |
| Edwards Intuity Elite Valve System (P150036/S041) | Edwards Lifesciences, LLC | 2019-09-24 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S099) | Edwards Lifesciences, LLC | 2019-09-24 |
| Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S092) | Edwards Lifesciences, LLC | 2019-09-24 |
| Edwards Pericardial Aortic/Mitral Bioprosthesis and Edwards Inspiris Resilia Aortic Valve (P150048/S037) | Edwards Lifesciences, LLC | 2019-09-24 |
| Sapien XT Transcatheter Heart Valve and Accessories (P130009/S100) | Edwards Lifesciences, LLC | 2019-09-17 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S094) | Edwards Lifesciences, LLC | 2019-09-17 |
| SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S091) | Edwards Lifesciences, LLC | 2019-08-21 |
| SAPIEN 3 Ultra transcatheter heart valve (P140031/S085) | Edwards Lifesciences, LLC | 2019-08-16 |
| SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S090) | Edwards Lifesciences, LLC | 2019-08-15 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S087) | Edwards Lifesciences, LLC | 2019-07-29 |
| Edwards Pericradial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S035) | Edwards Lifesciences, LLC | 2019-06-12 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S190) | Edwards Lifesciences, LLC | 2019-06-11 |
| Edwards Sapien 3 Transcatheter Heart Valve and Sapien 3 Ultra Transcatheter Heart Valve (P140031/S089) | Edwards Lifesciences, LLC | 2019-06-11 |
| Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve (P150048/S036) | Edwards Lifesciences, LLC | 2019-06-11 |
| Edwards Intuity Elite Valve System (P150036/S040) | Edwards Lifesciences, LLC | 2019-06-11 |
| SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S088) | Edwards Lifesciences, LLC | 2019-06-04 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprothesis (P150048/S032) | Edwards Lifesciences, LLC | 2019-04-04 |
| Edwards SAPIEN 3 (XT) Transcatheter Heart Valves (P130009/S097) | Edwards Lifesciences, LLC | 2019-03-19 |
| Edwards SAPIEN 3, SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S082) | Edwards Lifesciences, LLC | 2019-03-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S083) | Edwards Lifesciences, LLC | 2019-03-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S084) | Edwards Lifesciences, LLC | 2019-03-13 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S187) | Edwards Lifesciences, LLC | 2019-03-03 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S080) | Edwards Lifesciences, LLC | 2019-03-03 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S031) | Edwards Lifesciences, LLC | 2019-03-03 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S096) | Edwards Lifesciences, LLC | 2019-03-03 |
| EDWARDS INTUITY Elite Valve System (P150036/S037) | Edwards Lifesciences, LLC | 2019-03-03 |
| Certitude Introducer sheath set and Crimper (P140031/S081) | Edwards Lifesciences, LLC | 2019-02-18 |
| Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S023) | Edwards Lifesciences, LLC | 2018-12-28 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S074) | Edwards Lifesciences, LLC | 2018-12-27 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S079) | Edwards Lifesciences, LLC | 2018-12-03 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S030) | Edwards Lifesciences, LLC | 2018-12-03 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S095) | Edwards Lifesciences, LLC | 2018-12-03 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss (P860057/S186) | Edwards Lifesciences, LLC | 2018-12-03 |
| EDWARDS INTUITY Elite Valve System (P150036/S035) | Edwards Lifesciences, LLC | 2018-12-03 |
| Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis/Theon Pericardial Mitral Bioprosthesis with ThermaFix (P860057/S185) | Edwards Lifesciences, LLC | 2018-12-01 |
| EDWARDS INTUITY ELITE Valve/Delivery System (P150036/S036) | Edwards Lifesciences, LLC | 2018-12-01 |
| EDWARDS INTUITY Elite Valve System (P150036/S033) | Edwards Lifesciences, LLC | 2018-11-20 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S027) | Edwards Lifesciences, LLC | 2018-11-20 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S183) | Edwards Lifesciences, LLC | 2018-11-20 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S028) | Edwards Lifesciences, LLC | 2018-11-19 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S184) | Edwards Lifesciences, LLC | 2018-11-19 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S094) | Edwards Lifesciences, LLC | 2018-11-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S077) | Edwards Lifesciences, LLC | 2018-11-19 |
| EDWARDS INTUITY Elite Valve System (P150036/S034) | Edwards Lifesciences, LLC | 2018-11-19 |
| Edwards Commander Delivery System (P140031/S078) | Edwards Lifesciences, LLC | 2018-11-13 |
| Edwards Pericardial Mitral Bioprosthesis (P150048/S026) | Edwards Lifesciences, LLC | 2018-11-05 |
| Edwards Commander Delivery System (P140031/S076) | Edwards Lifesciences, LLC | 2018-10-25 |
| 9600CR Crimper (P140031/S075) | Edwards Lifesciences, LLC | 2018-10-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S072) | Edwards Lifesciences, LLC | 2018-09-05 |
| Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S093) | Edwards Lifesciences, LLC | 2018-09-05 |