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Edwards Lifesciences, LLC

1,178 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
SAPIEN 3 Transcatheter Heart Valve (23mm, 26mm, and 29mm (P140031/S073)Edwards Lifesciences, LLC2018-08-22
Edwards Pericardial Aortic Bioprosthesis / Edwards Inspiris Resilia Aortic Valve (P150048/S025)Edwards Lifesciences, LLC2018-08-15
Edwards Pericardial Mitral Bioprosthesis, Model 11000M (P150048/S012)Edwards Lifesciences, LLC2018-08-09
SAPIEN 3 Transcatheter Heart Valve (P140031/S071)Edwards Lifesciences, LLC2018-07-27
Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis, PERIMOUNT Magna Pericardial Aortic BIoprosthesis wi (P860057/S181)Edwards Lifesciences, LLC2018-07-27
Sapien 3 Transcatheter Heart Valve (P140031/S064)Edwards Lifesciences, LLC2018-07-26
EDWARDS INTUITY Elite Valve System (P150036/S032)Edwards Lifesciences, LLC2018-07-26
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S182)Edwards Lifesciences, LLC2018-07-26
Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S067)Edwards Lifesciences, LLC2018-07-23
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S024)Edwards Lifesciences, LLC2018-07-18
EDWARDS INTUITY ELITE Valve System (P150036/S031)Edwards Lifesciences, LLC2018-07-18
SAPIEN XT Transcatheter Heart Valve (P130009/S092)Edwards Lifesciences, LLC2018-07-18
SAPIEN 3 Transcatheter Heart Valve (P140031/S070)Edwards Lifesciences, LLC2018-07-18
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, PERIMOUNT Theon/Magna Pericardial Aortic Bioprosthesis wi (P860057/S180)Edwards Lifesciences, LLC2018-07-18
Edwards Certitude Introducer Sheath Set, Models 9600IS18, 9600IS21 (P140031/S069)Edwards Lifesciences, LLC2018-07-15
Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S068)Edwards Lifesciences, LLC2018-07-11
Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S091)Edwards Lifesciences, LLC2018-07-11
Edwards Pericardial Aortic Bioprosthesis (P150048/S005)Edwards Lifesciences, LLC2018-06-27
Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Model 11500A (P150048/S021)Edwards Lifesciences, LLC2018-06-20
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis / with ThermalFix tissue process/ RSR Pericardial Aortic B (P860057/S172)Edwards Lifesciences, LLC2018-06-13
EDWARDS INTUITY Valve System (P150036/S022)Edwards Lifesciences, LLC2018-06-13
Edwards Pericardial Aortic Bioprosthesis/ Edwards INSPIRIS RESILIA Aortic Valve (P150048/S011)Edwards Lifesciences, LLC2018-06-13
SAPIEN XT Transcatheter Heart Valve (P130009/S090)Edwards Lifesciences, LLC2018-05-31
SAPIEN 3 Transcatheter Heart Valve (P140031/S066)Edwards Lifesciences, LLC2018-05-31
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S022)Edwards Lifesciences, LLC2018-05-31
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic BIoprosthesis with ThermaFix tis (P860057/S179)Edwards Lifesciences, LLC2018-05-31
EDWARDS INTUITY ELITE Valve System (P150036/S030)Edwards Lifesciences, LLC2018-05-31
Edwards Intuity Elite Valve System, Aortic Valve Model 8300AB and Delivery System Model 8300DB (P150036/S029)Edwards Lifesciences, LLC2018-05-07
Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve (P150048/S020)Edwards Lifesciences, LLC2018-05-07
Edwards Sapien XT Transcatheter Heart Valve (P130009/S089)Edwards Lifesciences, LLC2018-05-07
Edwards Sapien 3 Transcatheter Heart Valve (P140031/S065)Edwards Lifesciences, LLC2018-05-07
Carpentier-Edwards Perimount Pericardial Bioprosthesis (P860057/S178)Edwards Lifesciences, LLC2018-05-07
Edwards Intuity Elite Valve System (P150036/S028)Edwards Lifesciences, LLC2018-04-12
Edwards Pericardial Aortic Bioprothesis, Inspiris Resilia Aortic Valve (P150048/S019)Edwards Lifesciences, LLC2018-04-12
Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Perimount Theon Pericardial Aortic Bioprothesis with Ther (P860057/S177)Edwards Lifesciences, LLC2018-04-12
Edwards Sapien 3 Transcatheter Heart Valve (P140031/S062)Edwards Lifesciences, LLC2018-04-12
Edwards Sapien XT Transcatheter Heart Valve (P130009/S087)Edwards Lifesciences, LLC2018-04-12
Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S060)Edwards Lifesciences, LLC2018-03-29
Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis/with ThermaFix tissue process; Carpentier-Edwards PE (P860057/S176)Edwards Lifesciences, LLC2018-03-29
Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S085)Edwards Lifesciences, LLC2018-03-29
Edwards Intuity Elite Valve System (P150036/S026)Edwards Lifesciences, LLC2018-03-29
Edwards Sapien 3 Transcatheter Heart Valve (P140031/S063)Edwards Lifesciences, LLC2018-03-28
Edwards Sapien XT Transcatheter Heart Valve (P130009/S088)Edwards Lifesciences, LLC2018-03-28
Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve (P150048/S018)Edwards Lifesciences, LLC2018-03-27
Edwards Intuity Elite Valve System (P150036/S027)Edwards Lifesciences, LLC2018-03-27
Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Carpentier-Edwards Perimount Theon Percardial Aortic Biop (P860057/S175)Edwards Lifesciences, LLC2018-03-27
Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S009)Edwards Lifesciences, LLC2018-03-16
Carpentier - Edwards Perimount Magna East Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S174)Edwards Lifesciences, LLC2018-03-12
Edwards Intuity Elite Valve System (P150036/S025)Edwards Lifesciences, LLC2018-03-12
Edwards Pericardial Aortic Bioprosthesis (Resilia tissue) (P150048/S016)Edwards Lifesciences, LLC2018-03-12
Ascendra+ and NovaFlex+ Delivery System, Crimper and Edwards Expandable Introducer Sheath Set (P130009/S086)Edwards Lifesciences, LLC2018-03-07
Edwards Pericardial Aortic Bioprosthesis (P150048/S014)Edwards Lifesciences, LLC2018-03-07
Edwards COmmander Delivery System (P140031/S061)Edwards Lifesciences, LLC2018-03-07
INSPIRIS RESILIA Aortic Valve (P150048/S015)Edwards Lifesciences, LLC2018-02-28
Edwards Pericardial Aortic Bioprosthesis and Inspiris Resilia Aortic (P150048/S017)Edwards Lifesciences, LLC2018-02-28
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S173)Edwards Lifesciences, LLC2018-02-03
Edwards Sapien XT Transcatheter Heart Valve (P130009/S084)Edwards Lifesciences, LLC2018-02-03
Edwards Sapien 3 Transcatheter Heart Valve (P140031/S059)Edwards Lifesciences, LLC2018-02-03
Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue) (P150048/S013)Edwards Lifesciences, LLC2018-02-03
EDWARDS INTUITY ELITE Valve System (P150036/S024)Edwards Lifesciences, LLC2018-02-03
EDWARDS INTUITY Elite Valve System (P150036/S019)Edwards Lifesciences, LLC2018-01-30
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis, Model 3300TFX (P860057/S169)Edwards Lifesciences, LLC2018-01-30
Edwards Pericardial Aortic Bioprosthesis (P150048/S006)Edwards Lifesciences, LLC2018-01-30
EDWARDS INTUITY Elite Valve System, Aortic Valve and Delivery System (P150036/S023)Edwards Lifesciences, LLC2018-01-19
Inspiris Resilia Aortic Valve (P150048/S003)Edwards Lifesciences, LLC2018-01-08
Final Crimp Stopper (P140031/S058)Edwards Lifesciences, LLC2017-12-11
Sapien 3 Transcatheter Heart Valve (P140031/S057)Edwards Lifesciences, LLC2017-12-11
EDWARDS INTUITY ELITE Valve System (P150036/S021)Edwards Lifesciences, LLC2017-12-08
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S171)Edwards Lifesciences, LLC2017-12-08
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S010)Edwards Lifesciences, LLC2017-12-08
RESILIA Aortic Valve (P150048/S008)Edwards Lifesciences, LLC2017-11-30
SAPIEN 3 Transcatheter Heart Valve (P140031/S055)Edwards Lifesciences, LLC2017-11-27
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S007)Edwards Lifesciences, LLC2017-11-27
SAPIEN XT Transcatheter Heart Valve (P130009/S083)Edwards Lifesciences, LLC2017-11-27
EDWARDS INTUITY ELITE Valve System (P150036/S020)Edwards Lifesciences, LLC2017-11-27
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with the ThermaFix (P860057/S170)Edwards Lifesciences, LLC2017-11-27
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S048)Edwards Lifesciences, LLC2017-11-20
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S047)Edwards Lifesciences, LLC2017-11-20
Edwards Commander Delivery System (P140031/S056)Edwards Lifesciences, LLC2017-11-13
Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S053)Edwards Lifesciences, LLC2017-10-04
Edwards Expandable Introducer Sheath Set (P130009/S082)Edwards Lifesciences, LLC2017-10-04
Edwards Commander Delivery System (P140031/S054)Edwards Lifesciences, LLC2017-10-03
Sapien 3 Transcatheter Heart Valve (P140031/S052)Edwards Lifesciences, LLC2017-09-28
Edwards Pericardial Aortic Bioprosthesis (P150048/S001)Edwards Lifesciences, LLC2017-09-21
Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss (P860057/S168)Edwards Lifesciences, LLC2017-09-07
Edwards Pericardial Aortic Bioprosthesis/Inspiris Resilia Aortic Valve (P150048/S004)Edwards Lifesciences, LLC2017-09-07
Edwards Intuity Elite Valve System (P150036/S018)Edwards Lifesciences, LLC2017-09-07
EDWARDS INTUITY Elite Valve System (P150036/S017)Edwards Lifesciences, LLC2017-08-31
Carpentier-Edwards PERIMOUNT Theon/RSR/Magna/Magna Ease Pericardial Aortic Bioprothesis / ThermaFix Tissue Process (P860057/S167)Edwards Lifesciences, LLC2017-08-24
EDWARDS INTUITY ELITE Valve System (P150036/S016)Edwards Lifesciences, LLC2017-08-24
Edwards Pericardial Aortic Bioprosthesis (P150048/S002)Edwards Lifesciences, LLC2017-08-21
Edwards Crimper model 9600CR (P140031/S041)Edwards Lifesciences, LLC2017-08-15
Sapien 3 - Transcatheter Heart Valve and Accessories (P140031/S051)Edwards Lifesciences, LLC2017-08-15
Carpentier-Edwars PERIMOUNT Pericardial Aortic Bioprosthesis/ ThermaFix tissue process; Carpentier-Edwards PERIMOUNT RSR (P860057/S166)Edwards Lifesciences, LLC2017-07-28
Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S081)Edwards Lifesciences, LLC2017-07-28
Edwards INTUITY Elite Valve System (P150036/S015)Edwards Lifesciences, LLC2017-07-28
Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S050)Edwards Lifesciences, LLC2017-07-28
Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat (P130009/S080)Edwards Lifesciences, LLC2017-07-27
Commander Delivery System; Certitude Delivery System; Certitude Introducer Sheath; Crimper (P140031/S049)Edwards Lifesciences, LLC2017-07-27
Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S046)Edwards Lifesciences, LLC2017-07-20
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