| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS (P010041/S050) | Edwards Lifesciences, LLC | 2014-05-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S037) | Edwards Lifesciences, LLC | 2014-05-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S050) | Edwards Lifesciences, LLC | 2014-05-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S040) | Edwards Lifesciences, LLC | 2014-05-16 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S053) | Edwards Lifesciences, LLC | 2014-05-16 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDFIAL AORTIC BIOPROSTHESIS (P860057/S124) | Edwards Lifesciences, LLC | 2014-05-13 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S039) | Edwards Lifesciences, LLC | 2014-05-01 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S052) | Edwards Lifesciences, LLC | 2014-05-01 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S123) | Edwards Lifesciences, LLC | 2014-05-01 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL (P860057/S122) | Edwards Lifesciences, LLC | 2014-04-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S038) | Edwards Lifesciences, LLC | 2014-04-17 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S051) | Edwards Lifesciences, LLC | 2014-04-17 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S028) | Edwards Lifesciences, LLC | 2014-03-28 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S041) | Edwards Lifesciences, LLC | 2014-03-28 |
| CARPENTIER-EDEARDS DURAFLEX LOW PRESSURE PROCINE MITRAL BIOPROSTHESIS (P870077/S060) | Edwards Lifesciences, LLC | 2014-03-27 |
| CARPENTIER-EDWARDS PROCINE AORTIC BIOPROSTHESIS ,PROCINE MITRAL BIOPROSTHESIS (P870056/S066) | Edwards Lifesciences, LLC | 2014-03-27 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S049) | Edwards Lifesciences, LLC | 2014-03-27 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S045) | Edwards Lifesciences, LLC | 2014-03-27 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S049) | Edwards Lifesciences, LLC | 2014-03-27 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S036) | Edwards Lifesciences, LLC | 2014-03-27 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS WITH TERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIOP (P860057/S120) | Edwards Lifesciences, LLC | 2014-03-27 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S119) | Edwards Lifesciences, LLC | 2014-03-14 |
| CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESIS (P870056/S065) | Edwards Lifesciences, LLC | 2014-03-14 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S048) | Edwards Lifesciences, LLC | 2014-03-14 |
| DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE (P870077/S059) | Edwards Lifesciences, LLC | 2014-03-14 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S035) | Edwards Lifesciences, LLC | 2014-03-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S048) | Edwards Lifesciences, LLC | 2014-03-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S034) | Edwards Lifesciences, LLC | 2014-02-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S047) | Edwards Lifesciences, LLC | 2014-02-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S037) | Edwards Lifesciences, LLC | 2014-01-31 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S024) | Edwards Lifesciences, LLC | 2014-01-31 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROTHESIS,CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICA (P860057/S116) | Edwards Lifesciences, LLC | 2014-01-24 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S117) | Edwards Lifesciences, LLC | 2014-01-23 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROTHESIS (P870056/S064) | Edwards Lifesciences, LLC | 2014-01-23 |
| DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING (P870077/S058) | Edwards Lifesciences, LLC | 2014-01-23 |
| CARPENTIER-EDWARDS SAV AORTIC PORCINE BIOPROSTHESIS (P010041/S047) | Edwards Lifesciences, LLC | 2014-01-23 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROTHESIS (P000007/S044) | Edwards Lifesciences, LLC | 2013-12-19 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESES DEVICE FAMILIES (P860057/S115) | Edwards Lifesciences, LLC | 2013-12-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S033) | Edwards Lifesciences, LLC | 2013-12-19 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING,CARPENTIER-EDWARDS DURAFLEX LOW (P870077/S057) | Edwards Lifesciences, LLC | 2013-12-19 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS (P010041/S046) | Edwards Lifesciences, LLC | 2013-12-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S046) | Edwards Lifesciences, LLC | 2013-12-19 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS,PORCINE VALVED CONDUIT (P870056/S063) | Edwards Lifesciences, LLC | 2013-12-19 |
| EDWARD SAPIEN TRANSCATHETER HEART VALVE AND ACCESSIRUES (P110021/S029) | Edwards Lifesciences, LLC | 2013-11-26 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S042) | Edwards Lifesciences, LLC | 2013-11-26 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S114) | Edwards Lifesciences, LLC | 2013-11-26 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S030) | Edwards Lifesciences, LLC | 2013-11-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S043) | Edwards Lifesciences, LLC | 2013-11-18 |
| CARPENTIER - EDEARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S113) | Edwards Lifesciences, LLC | 2013-10-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES-RETROFLEX 3 DELIVERY SYSTEM, EDWARDS TRANSFEMORAL BALLOON CATHE (P100041/S040) | Edwards Lifesciences, LLC | 2013-10-11 |
| CARTENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING (P870077/S056) | Edwards Lifesciences, LLC | 2013-10-11 |
| CARPENTIER- EDWARDS PORCINE BIOPROSTHESIS (P870056/S062) | Edwards Lifesciences, LLC | 2013-10-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, CRIMPER ASCENDRA BALLOON CATHETER (P110021/S027) | Edwards Lifesciences, LLC | 2013-10-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S043) | Edwards Lifesciences, LLC | 2013-10-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S045) | Edwards Lifesciences, LLC | 2013-10-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S044) | Edwards Lifesciences, LLC | 2013-09-23 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S112) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S039) | Edwards Lifesciences, LLC | 2013-09-23 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LOW (P870077/S055) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S042) | Edwards Lifesciences, LLC | 2013-09-23 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S061) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S026) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S038) | Edwards Lifesciences, LLC | 2013-09-20 |
| CARPENTIER EDWARDS PERIMOUNT PERICARDIAL AOTRIC BIOPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS, RSRTHEON (P860057/S111) | Edwards Lifesciences, LLC | 2013-09-20 |
| EDWARDS SAPIEN TRANSCATHER HEART VALVE (P110021/S025) | Edwards Lifesciences, LLC | 2013-09-20 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S023) | Edwards Lifesciences, LLC | 2013-09-13 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS (P860057/S110) | Edwards Lifesciences, LLC | 2013-08-16 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S036) | Edwards Lifesciences, LLC | 2013-08-09 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S022) | Edwards Lifesciences, LLC | 2013-08-09 |
| EDWARDS SAPIEN TRANSCATHER HEART VALVE, MODEL 9000TFX (P110021/S021) | Edwards Lifesciences, LLC | 2013-08-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART, MODEL 9000TFX (P100041/S035) | Edwards Lifesciences, LLC | 2013-08-02 |
| EDWARDS SAPIEN TRANSCATETER HEART VALVE AN TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S020) | Edwards Lifesciences, LLC | 2013-07-22 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S034) | Edwards Lifesciences, LLC | 2013-07-22 |
| CARPENTIER-EDWARDS BIOSPROSTHETIC PULMONIC VALVED CONDUIT (P870056/S060) | Edwards Lifesciences, LLC | 2013-07-16 |
| TRANSCATHER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S019) | Edwards Lifesciences, LLC | 2013-07-11 |
| TRANSCATHER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S033) | Edwards Lifesciences, LLC | 2013-07-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S017) | Edwards Lifesciences, LLC | 2013-07-03 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S032) | Edwards Lifesciences, LLC | 2013-07-03 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S018) | Edwards Lifesciences, LLC | 2013-07-03 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S031) | Edwards Lifesciences, LLC | 2013-07-03 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES (P110021/S004) | Edwards Lifesciences, LLC | 2013-07-02 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, MITRAL BIOPROSTHESIS,; BIOPROSTHESIS VALVED CONDUIT; DURAFLEX LOW PRES (P870056/S059) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S030) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P100041/S029) | Edwards Lifesciences, LLC | 2013-06-25 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S043) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P110021/S015) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S016) | Edwards Lifesciences, LLC | 2013-06-25 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AORTIC BIOPROSTHESIS, RSR PERICARDIAL (P860057/S109) | Edwards Lifesciences, LLC | 2013-06-25 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS; BIOPROSTHESIS-EDWARDS DURAFLEX LOW PRESSURE MITRA (P870077/S054) | Edwards Lifesciences, LLC | 2013-06-25 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S041) | Edwards Lifesciences, LLC | 2013-06-25 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S051) | Edwards Lifesciences, LLC | 2013-06-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S019) | Edwards Lifesciences, LLC | 2013-06-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S100) | Edwards Lifesciences, LLC | 2013-06-11 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S056) | Edwards Lifesciences, LLC | 2013-06-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S040) | Edwards Lifesciences, LLC | 2013-06-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S005) | Edwards Lifesciences, LLC | 2013-06-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S038) | Edwards Lifesciences, LLC | 2013-06-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S108) | Edwards Lifesciences, LLC | 2013-06-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM (P110021/S014) | Edwards Lifesciences, LLC | 2013-06-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM (P100041/S028) | Edwards Lifesciences, LLC | 2013-06-10 |