| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S068) | Edwards Lifesciences, LLC | 2016-03-18 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S143) | Edwards Lifesciences, LLC | 2016-03-17 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S049) | Edwards Lifesciences, LLC | 2016-03-17 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S002) | Edwards Lifesciences, LLC | 2016-03-16 |
| SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S037) | Edwards Lifesciences, LLC | 2016-02-29 |
| EDWARDS COMMANDER DELIVERY SYSTEM (P140031/S007) | Edwards Lifesciences, LLC | 2016-02-22 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S046) | Edwards Lifesciences, LLC | 2016-02-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S048) | Edwards Lifesciences, LLC | 2016-02-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S047) | Edwards Lifesciences, LLC | 2016-02-16 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S008) | Edwards Lifesciences, LLC | 2016-02-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S045) | Edwards Lifesciences, LLC | 2016-02-10 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S006) | Edwards Lifesciences, LLC | 2016-02-10 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS. RSR PERICARDIAL AORTIC BIOPROSTHESIS, MAGNA PERICARDIAL A (P860057/S141) | Edwards Lifesciences, LLC | 2016-02-10 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S003) | Edwards Lifesciences, LLC | 2016-01-26 |
| NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S044) | Edwards Lifesciences, LLC | 2016-01-08 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (26MM SIZE ONLY) (P140031/S004) | Edwards Lifesciences, LLC | 2016-01-04 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S005) | Edwards Lifesciences, LLC | 2016-01-04 |
| NOVAFLEX+ DELIVERY SYSTEM (P130009/S043) | Edwards Lifesciences, LLC | 2015-12-21 |
| ASCENDRA+ DELIVERY SYSTEM, NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET CRIMPER, QUALCRIMP CRIMPI (P130009/S042) | Edwards Lifesciences, LLC | 2015-12-11 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S028) | Edwards Lifesciences, LLC | 2015-12-07 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S065) | Edwards Lifesciences, LLC | 2015-12-07 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S052) | Edwards Lifesciences, LLC | 2015-12-07 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S139) | Edwards Lifesciences, LLC | 2015-10-27 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S041) | Edwards Lifesciences, LLC | 2015-10-27 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; EDWARDS QUALCRIMP CRIMPING ACCESSORY (P130009/S004) | Edwards Lifesciences, LLC | 2015-10-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S042) | Edwards Lifesciences, LLC | 2015-10-19 |
| CARPENTIER-EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AOTIC BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS (P860057/S127) | Edwards Lifesciences, LLC | 2015-10-19 |
| EDWARDS SAPIEN TRANSCATHER HEART VALVE (P100041/S055) | Edwards Lifesciences, LLC | 2015-10-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S034) | Edwards Lifesciences, LLC | 2015-10-09 |
| ASCENDRA+ DELIVERY SYSTEM (P130009/S038) | Edwards Lifesciences, LLC | 2015-09-02 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS; THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX TI (P860057/S138) | Edwards Lifesciences, LLC | 2015-08-07 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S001) | Edwards Lifesciences, LLC | 2015-08-07 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S040) | Edwards Lifesciences, LLC | 2015-08-07 |
| ASCENDRA + DELIVERY SYSTEM (P130009/S039) | Edwards Lifesciences, LLC | 2015-08-07 |
| NOVAFLEX DELIVERY SYSTEM (P130009/S016) | Edwards Lifesciences, LLC | 2015-07-21 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S036) | Edwards Lifesciences, LLC | 2015-06-18 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTH (P860057/S137) | Edwards Lifesciences, LLC | 2015-06-18 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S035) | Edwards Lifesciences, LLC | 2015-06-17 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031) | Edwards Lifesciences, LLC | 2015-06-17 |
| CARPENTIER-EDWARDS PERIMOUNT AORTIC & MITRAL BIOPROSTHESIS FAMILIES (P860057/S135) | Edwards Lifesciences, LLC | 2015-06-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BI (P860057/S136) | Edwards Lifesciences, LLC | 2015-04-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S031) | Edwards Lifesciences, LLC | 2015-04-16 |
| CARPENTER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE FAMILIES (P860057/S134) | Edwards Lifesciences, LLC | 2015-04-16 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S032) | Edwards Lifesciences, LLC | 2015-04-13 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S029) | Edwards Lifesciences, LLC | 2015-03-20 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S053) | Edwards Lifesciences, LLC | 2015-03-20 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S066) | Edwards Lifesciences, LLC | 2015-03-20 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S064) | Edwards Lifesciences, LLC | 2015-02-27 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S027) | Edwards Lifesciences, LLC | 2015-02-27 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S051) | Edwards Lifesciences, LLC | 2015-02-27 |
| ASCENDRA + DELIVERY SYSTEM (P130009/S025) | Edwards Lifesciences, LLC | 2015-02-25 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S026) | Edwards Lifesciences, LLC | 2015-02-13 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S024) | Edwards Lifesciences, LLC | 2015-02-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S063) | Edwards Lifesciences, LLC | 2015-02-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, WITH THERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIO (P860057/S132) | Edwards Lifesciences, LLC | 2015-02-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S050) | Edwards Lifesciences, LLC | 2015-02-11 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S023) | Edwards Lifesciences, LLC | 2015-02-05 |
| EDWARDS SAPIEN CT TRANSCATHETER HEART VALVE (P130009/S022) | Edwards Lifesciences, LLC | 2015-01-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S049) | Edwards Lifesciences, LLC | 2015-01-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S131) | Edwards Lifesciences, LLC | 2015-01-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S062) | Edwards Lifesciences, LLC | 2015-01-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIIAL AORTIC BIOPROSTHESIS, THEON PERICARDINAL AORTIC BIOPROSTHESIS WITH THERMAFIX T (P860057/S130) | Edwards Lifesciences, LLC | 2015-01-12 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S019) | Edwards Lifesciences, LLC | 2014-12-15 |
| NOVAFLEX + DELIVERY SYSTEM (P130009/S017) | Edwards Lifesciences, LLC | 2014-12-05 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S061) | Edwards Lifesciences, LLC | 2014-11-25 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S018) | Edwards Lifesciences, LLC | 2014-11-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S048) | Edwards Lifesciences, LLC | 2014-11-25 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S015) | Edwards Lifesciences, LLC | 2014-11-14 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS; RSR, THEON RSR WITH (P860057/S129) | Edwards Lifesciences, LLC | 2014-11-14 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S060) | Edwards Lifesciences, LLC | 2014-11-14 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S047) | Edwards Lifesciences, LLC | 2014-11-14 |
| ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER (P110021/S046) | Edwards Lifesciences, LLC | 2014-10-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S014) | Edwards Lifesciences, LLC | 2014-10-23 |
| NOVAFLEX+ DELIVERY SYSTEM, ASCENDRA+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, ASCENDRA+ INTRODUCER SHE (P130009/S013) | Edwards Lifesciences, LLC | 2014-10-23 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) (P130009/S012) | Edwards Lifesciences, LLC | 2014-10-20 |
| SAPIEN TRANSCATHETER HEART VALVE (THV) (P110021/S045) | Edwards Lifesciences, LLC | 2014-10-20 |
| SAPIEN TRANSCATHETER HEART VALVE (THV) (P100041/S059) | Edwards Lifesciences, LLC | 2014-10-20 |
| CARPENTIER-EDWARDS PERIMOUNT MITRA & AORTIC,THEON,RSR,THEON RSR,MAGNA,MAGNA EASE WITH& WITHOUT THERMAFEX TISSUE PROCESS (P860057/S128) | Edwards Lifesciences, LLC | 2014-10-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S058) | Edwards Lifesciences, LLC | 2014-10-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S044) | Edwards Lifesciences, LLC | 2014-10-02 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S011) | Edwards Lifesciences, LLC | 2014-10-02 |
| EDWARDS NOVAFLEX+ DELIVERY SYSTEM (P130009/S009) | Edwards Lifesciences, LLC | 2014-09-30 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S010) | Edwards Lifesciences, LLC | 2014-09-29 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S002) | Edwards Lifesciences, LLC | 2014-09-12 |
| SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE (P100041/S056) | Edwards Lifesciences, LLC | 2014-08-28 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S126) | Edwards Lifesciences, LLC | 2014-08-11 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S005) | Edwards Lifesciences, LLC | 2014-08-07 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S003) | Edwards Lifesciences, LLC | 2014-08-07 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S054) | Edwards Lifesciences, LLC | 2014-08-04 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S001) | Edwards Lifesciences, LLC | 2014-08-04 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S118) | Edwards Lifesciences, LLC | 2014-08-04 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S041) | Edwards Lifesciences, LLC | 2014-08-04 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S125) | Edwards Lifesciences, LLC | 2014-06-18 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009) | Edwards Lifesciences, LLC | 2014-06-16 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S031) | Edwards Lifesciences, LLC | 2014-06-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S044) | Edwards Lifesciences, LLC | 2014-06-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S046) | Edwards Lifesciences, LLC | 2014-05-20 |
| CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROTHESIS (P870056/S067) | Edwards Lifesciences, LLC | 2014-05-19 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S121) | Edwards Lifesciences, LLC | 2014-05-19 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LO (P870077/S061) | Edwards Lifesciences, LLC | 2014-05-19 |