| EDWARDS INTUITY ELITE Valve System (P150036/S014) | Edwards Lifesciences, LLC | 2017-07-20 |
| EDWARDS SAPIEN XT Transcatheter Heart Valve (P130009/S079) | Edwards Lifesciences, LLC | 2017-07-20 |
| Carpentier-Edwards PERIMOUNT RSR Theon/Magna/Plus Pericardial Aortic Bioprosthesis with ThermalFix tissue process, (P860057/S165) | Edwards Lifesciences, LLC | 2017-07-20 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S045) | Edwards Lifesciences, LLC | 2017-07-18 |
| Carpentier-Edwards® PERIMOUNT® Pericardial/RSR/Magna/Magna Ease Aortic/ Plus/ Theon Pericardial Mitral Bioprosthesis wit (P860057/S164) | Edwards Lifesciences, LLC | 2017-07-18 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S078) | Edwards Lifesciences, LLC | 2017-07-18 |
| EDWARDS INTUITY Valve System (P150036/S013) | Edwards Lifesciences, LLC | 2017-07-18 |
| EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) (P150048) | Edwards Lifesciences, LLC | 2017-06-29 |
| Sapien XT Transcatheter Heart Valve (P130009/S077) | Edwards Lifesciences, LLC | 2017-06-22 |
| Sapien 3 Transcatheter Heart Valve (P140031/S043) | Edwards Lifesciences, LLC | 2017-06-22 |
| Perimount Aortic and Mitral Bioprostheses (P860057/S163) | Edwards Lifesciences, LLC | 2017-06-20 |
| Sapien XT Transcatheter Heart Valve (P130009/S076) | Edwards Lifesciences, LLC | 2017-06-20 |
| EDWARDS INTUITY VALVE SYSTEM (P150036/S002) | Edwards Lifesciences, LLC | 2017-06-20 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESES/ THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX T (P860057/S156) | Edwards Lifesciences, LLC | 2017-06-20 |
| Sapien S3 Transcatheter Heart Valve (P140031/S042) | Edwards Lifesciences, LLC | 2017-06-20 |
| Intuity Elite Valve System (P150036/S012) | Edwards Lifesciences, LLC | 2017-06-20 |
| Edwards Commander Delivery System (P140031/S044) | Edwards Lifesciences, LLC | 2017-06-16 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/ Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S162) | Edwards Lifesciences, LLC | 2017-06-09 |
| Edwards Intuity Valve System (P150036/S011) | Edwards Lifesciences, LLC | 2017-06-09 |
| Edwards Crimper (P140031/S035) | Edwards Lifesciences, LLC | 2017-06-07 |
| Edwards SAPIEN 3 Transcatheter Heart Vlave (P140031/S034) | Edwards Lifesciences, LLC | 2017-06-06 |
| Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S028) | Edwards Lifesciences, LLC | 2017-06-05 |
| Edwards Intuity Elite Valve & Delivery System (P150036/S010) | Edwards Lifesciences, LLC | 2017-05-25 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S074) | Edwards Lifesciences, LLC | 2017-05-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S039) | Edwards Lifesciences, LLC | 2017-05-23 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bio (P860057/S160) | Edwards Lifesciences, LLC | 2017-05-23 |
| EDWARDS INTUITY Valve System (P150036/S008) | Edwards Lifesciences, LLC | 2017-05-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S038) | Edwards Lifesciences, LLC | 2017-05-10 |
| EDWARDS INTUITY Valve System (P150036/S007) | Edwards Lifesciences, LLC | 2017-05-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S073) | Edwards Lifesciences, LLC | 2017-05-10 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis (P860057/S159) | Edwards Lifesciences, LLC | 2017-05-10 |
| EDWARDS INTUITY VALVE SYSTEM (P150036/S001) | Edwards Lifesciences, LLC | 2017-05-01 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VAlVE (P130009/S066) | Edwards Lifesciences, LLC | 2017-05-01 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S154) | Edwards Lifesciences, LLC | 2017-05-01 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S025) | Edwards Lifesciences, LLC | 2017-05-01 |
| NovaFlex+ Delivery System (P130009/S072) | Edwards Lifesciences, LLC | 2017-04-20 |
| Edwards Commander Delivery System (P140031/S037) | Edwards Lifesciences, LLC | 2017-04-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S036) | Edwards Lifesciences, LLC | 2017-04-07 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S071) | Edwards Lifesciences, LLC | 2017-04-07 |
| Carpentier-Edwards PERIMOUNT pericardial Bioprostheses (P860057/S158) | Edwards Lifesciences, LLC | 2017-04-07 |
| EDWARDS INTUITY Elite Valve System (P150036/S006) | Edwards Lifesciences, LLC | 2017-04-07 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S033) | Edwards Lifesciences, LLC | 2017-04-03 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S068) | Edwards Lifesciences, LLC | 2017-04-03 |
| SAPIEN XT Transcatheter Heart Valve (Frame only) Ascendra+Delivery System/NovaFlex+Delivery System/Edwards Expandable In (P130009/S070) | Edwards Lifesciences, LLC | 2017-03-09 |
| SAPIEN 3 Transcatheter Heart Valve (Frame only) Commander Delivery System/Certitude Delivery System/ Certitude Introduce (P140031/S032) | Edwards Lifesciences, LLC | 2017-03-09 |
| EDWARDS COMMANDER DELIVERY SYSTEM (P140031/S030) | Edwards Lifesciences, LLC | 2017-03-01 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036/S005) | Edwards Lifesciences, LLC | 2017-02-28 |
| QUALCRIMP CRIMPING ACCESSORY (LAMINATED) (P140031/S031) | Edwards Lifesciences, LLC | 2017-02-27 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB) (P150036/S004) | Edwards Lifesciences, LLC | 2017-02-16 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S157) | Edwards Lifesciences, LLC | 2017-01-19 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036/S003) | Edwards Lifesciences, LLC | 2017-01-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S029) | Edwards Lifesciences, LLC | 2017-01-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S069) | Edwards Lifesciences, LLC | 2017-01-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S027) | Edwards Lifesciences, LLC | 2016-12-14 |
| Qualcrimp crimping accessory (Packaged with the Commander Delivery System) (P140031/S026) | Edwards Lifesciences, LLC | 2016-12-13 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S142) | Edwards Lifesciences, LLC | 2016-12-13 |
| Qualcrimp crimping accessory (Packaged with the NovaFlex+ Delivery System) (P130009/S067) | Edwards Lifesciences, LLC | 2016-12-13 |
| Edwards Certitude Delivery System (P140031/S024) | Edwards Lifesciences, LLC | 2016-12-02 |
| Commander Delivery System (Including Loader) (P140031/S018) | Edwards Lifesciences, LLC | 2016-11-17 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S065) | Edwards Lifesciences, LLC | 2016-11-10 |
| NEW BRANSON ULTRASONIC WELDER GENII (P860057/S147) | Edwards Lifesciences, LLC | 2016-10-28 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per (P860057/S152) | Edwards Lifesciences, LLC | 2016-10-20 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S023) | Edwards Lifesciences, LLC | 2016-09-25 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S053) | Edwards Lifesciences, LLC | 2016-09-20 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S064) | Edwards Lifesciences, LLC | 2016-09-19 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S153) | Edwards Lifesciences, LLC | 2016-09-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S022) | Edwards Lifesciences, LLC | 2016-09-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (THV), MODEL 9600TFX (P140031/S021) | Edwards Lifesciences, LLC | 2016-09-08 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S019) | Edwards Lifesciences, LLC | 2016-09-06 |
| EDWARDS CRIMPER (P140031/S020) | Edwards Lifesciences, LLC | 2016-08-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S062) | Edwards Lifesciences, LLC | 2016-08-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S015) | Edwards Lifesciences, LLC | 2016-08-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S057) | Edwards Lifesciences, LLC | 2016-08-18 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S010) | Edwards Lifesciences, LLC | 2016-08-18 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036) | Edwards Lifesciences, LLC | 2016-08-12 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S061) | Edwards Lifesciences, LLC | 2016-08-02 |
| Edwards Expandable Introducer Sheath Set (P130009/S063) | Edwards Lifesciences, LLC | 2016-07-21 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S150) | Edwards Lifesciences, LLC | 2016-07-05 |
| Carpentier-Edwards PERIMOUNT (P860057/S151) | Edwards Lifesciences, LLC | 2016-07-01 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S060) | Edwards Lifesciences, LLC | 2016-06-27 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS (P860057/S149) | Edwards Lifesciences, LLC | 2016-06-23 |
| EDWARD SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S017) | Edwards Lifesciences, LLC | 2016-06-10 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S059) | Edwards Lifesciences, LLC | 2016-06-10 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S058) | Edwards Lifesciences, LLC | 2016-05-23 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S016) | Edwards Lifesciences, LLC | 2016-05-23 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S146) | Edwards Lifesciences, LLC | 2016-05-06 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S055) | Edwards Lifesciences, LLC | 2016-05-06 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S013) | Edwards Lifesciences, LLC | 2016-05-06 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S052) | Edwards Lifesciences, LLC | 2016-04-13 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S054) | Edwards Lifesciences, LLC | 2016-04-06 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S012) | Edwards Lifesciences, LLC | 2016-03-25 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S051) | Edwards Lifesciences, LLC | 2016-03-22 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S145) | Edwards Lifesciences, LLC | 2016-03-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S056) | Edwards Lifesciences, LLC | 2016-03-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S069) | Edwards Lifesciences, LLC | 2016-03-22 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S011) | Edwards Lifesciences, LLC | 2016-03-22 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S050) | Edwards Lifesciences, LLC | 2016-03-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S055) | Edwards Lifesciences, LLC | 2016-03-18 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S009) | Edwards Lifesciences, LLC | 2016-03-18 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S144) | Edwards Lifesciences, LLC | 2016-03-18 |