FDA.report

Product code DYE

Current FDA Classification

Device name
Replacement Heart-Valve
Medical specialty
Cardiovascular
Device class
3
Regulation number
870.3925
Review panel
CV
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))

Related PMA Records

PMADeviceApplicantDecision date
P860057S195Carpentier-Edwards Perimount Aortic Bioprostheses and Carpentier-Edwards Perimount Mitral BioprosthesesEDWARDS LIFESCIENCES, LLC.2019-11-26
P860057S194Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR PericardialEDWARDS LIFESCIENCES, LLC.2019-11-24
P860057S193Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR PericardialEDWARDS LIFESCIENCES, LLC.2019-11-18
P860057S192Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus BiEDWARDS LIFESCIENCES, LLC.2019-10-28
P860057S191Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PEREDWARDS LIFESCIENCES, LLC.2019-09-24
P980043S071Hancock II BioprosthesisMedtronic, Inc.2019-07-17
P870078S046Hancock Valved ConduitMedtronic, Inc.2019-07-17
P990064S079Mosaic BioprosthesisMedtronic, Inc.2019-07-17
P860057S190Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tisEDWARDS LIFESCIENCES, LLC.2019-06-11
P990064S078Mosaic Porcine Bioprosthetic Heart ValveMedtronic, Inc.2019-03-03
P980043S070Hancock II Porcine BioprosthesisMedtronic, Inc.2019-03-03
P870078S045Hancock Valved Conduit MOMedtronic, Inc.2019-03-03
P860057S187Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tisEDWARDS LIFESCIENCES, LLC.2019-03-03
P860057S186Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tissEDWARDS LIFESCIENCES, LLC.2018-12-03
P860057S185Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis/Theon Pericardial Mitral Bioprosthesis with ThermaFixEDWARDS LIFESCIENCES, LLC.2018-12-01
P860057S183Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tisEDWARDS LIFESCIENCES, LLC.2018-11-20
P860057S184Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tisEDWARDS LIFESCIENCES, LLC.2018-11-19
P870078S043Hancock Valved Conduit Low PorosityMedtronic, Inc.2018-10-28
P990064S076Mosaic Bioprosthesis and Hancock II BioprosthesisMedtronic, Inc.2018-10-22
P980043S068Mosaic Bioprosthesis and Hancock II BioprosthesisMedtronic, Inc.2018-10-22
P860057S181Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis, PERIMOUNT Magna Pericardial Aortic BIoprosthesis wiEDWARDS LIFESCIENCES, LLC.2018-07-27
P860057S182Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tisEDWARDS LIFESCIENCES, LLC.2018-07-26
P860057S180Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, PERIMOUNT Theon/Magna Pericardial Aortic Bioprosthesis wiEDWARDS LIFESCIENCES, LLC.2018-07-18
P980043S067Hancock II BioprosthesisMedtronic, Inc.2018-06-29
P870078S042Hancock Valved ConduitMedtronic, Inc.2018-06-29
P860057S172Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis / with ThermalFix tissue process/ RSR Pericardial Aortic BEDWARDS LIFESCIENCES, LLC.2018-06-13
P860057S179Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic BIoprosthesis with ThermaFix tisEDWARDS LIFESCIENCES, LLC.2018-05-31
P860057S178Carpentier-Edwards Perimount Pericardial BioprosthesisEDWARDS LIFESCIENCES, LLC.2018-05-07
P990064S075Mosaic Procine BioprosthesisMedtronic, Inc.2018-04-19
P980043S066Hancock II Porcine BioprosthesisMedtronic, Inc.2018-04-19

Related GUDID Devices

Primary DIBrandCompanyPublished
00763000926472Hancock™ 150MEDTRONIC, INC.2024-07-22
00763000926465Hancock™ 150MEDTRONIC, INC.2024-07-22
00643169983229Avalus™MEDTRONIC, INC.2024-03-09
00690103194104CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLC2019-11-27
00690103194098CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLC2019-11-27
00690103194081CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTICEdwards Lifesciences LLC2019-11-27
00690103194074CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTICEdwards Lifesciences LLC2019-11-27
00690103194128CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLC2019-08-09
00690103194067CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2019-02-21
00690103194050CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2019-02-21
00690103194043CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2019-02-21
00690103194036CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2019-02-21
00690103194029CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2019-02-21
00690103194012CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2019-02-21
00681490908504HANCOCK®MEDTRONIC, INC.2014-09-23
00681490908740HANCOCK®MEDTRONIC, INC.2014-09-23
00681490908726HANCOCK®MEDTRONIC, INC.2014-09-23
00681490908696HANCOCK®MEDTRONIC, INC.2014-09-23
00681490908641HANCOCK®MEDTRONIC, INC.2014-09-23
00681490908597HANCOCK®MEDTRONIC, INC.2014-09-23
00681490908559HANCOCK®MEDTRONIC, INC.2014-09-23
00681490908528HANCOCK®MEDTRONIC, INC.2014-09-23
00681490908474HANCOCK®MEDTRONIC, INC.2014-09-23
00690103021516CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2014-08-30
00690103021523CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2014-08-30
00690103021530CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2014-08-30
00690103021547CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2014-08-30
00690103021554CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2014-08-30
00690103021561CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2014-08-30
00690103021578CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2014-08-30