FDA.reportPublic FDA data

Aortic heart valve bioprosthesis

Definition
A sterile xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.
GUDID devices
290
Last updated
2021-02-03 09:40:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00896208000795PERCEVAL PLUSCorcym Canada CorpPVF-S2021-01-26
00896208000801PERCEVAL PLUSCorcym Canada CorpPVF-M2021-01-26
00896208000818PERCEVAL PLUSCorcym Canada CorpPVF-L2021-01-26
00896208000825PERCEVAL PLUSCorcym Canada CorpPVF-XL2021-01-26
00690103194012CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2700TFX2019-02-21
00690103194029CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2700TFX2019-02-21
00690103194036CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2700TFX2019-02-21
00690103194043CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2700TFX2019-02-21
00690103194050CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2700TFX2019-02-21
00690103194067CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLC2700TFX2019-02-21
00690103194128CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLC2800TFX2019-08-09
00690103194074CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTICEdwards Lifesciences LLC2800TFX2019-11-27
00690103194081CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTICEdwards Lifesciences LLC2800TFX2019-11-27
00690103194098CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLC2800TFX2019-11-27
00690103194104CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLC2800TFX2019-11-27
05414734052016Trifecta™ST. JUDE MEDICAL, INC.TF-19A2014-09-23
05414734052023Trifecta™ST. JUDE MEDICAL, INC.TF-21A2014-09-23
05414734052030Trifecta™ST. JUDE MEDICAL, INC.TF-23A2014-09-23
05414734052047Trifecta™ST. JUDE MEDICAL, INC.TF-25A2014-09-23
05414734052054Trifecta™ST. JUDE MEDICAL, INC.TF-27A2014-09-23
05414734052061Trifecta™ST. JUDE MEDICAL, INC.TF-29A2014-09-23
05415067018205Trifecta™ST. JUDE MEDICAL, INC.TFGT-19A2016-04-27
05415067018212Trifecta™ST. JUDE MEDICAL, INC.TFGT-21A2016-04-27
05415067018229Trifecta™ST. JUDE MEDICAL, INC.TFGT-23A2016-04-27
05415067018236Trifecta™ST. JUDE MEDICAL, INC.TFGT-25A2016-04-27
05415067018243Trifecta™ST. JUDE MEDICAL, INC.TFGT-27A2016-04-27
05415067018250Trifecta™ST. JUDE MEDICAL, INC.TFGT-29A2016-04-27
00885074133102MOSAIC®MEDTRONIC, INC.305C192014-09-23
00885074133126MOSAIC®MEDTRONIC, INC.305C232014-09-23
00885074133133MOSAIC®MEDTRONIC, INC.305C252014-09-23
00885074253213MOSAIC ULTRA®MEDTRONIC, INC.305U192014-09-23
00885074253220MOSAIC ULTRA®MEDTRONIC, INC.305U212014-09-23
00885074253244MOSAIC ULTRA®MEDTRONIC, INC.305U232014-09-23
00885074253251MOSAIC ULTRA®MEDTRONIC, INC.305U252014-09-23
00885074253268MOSAIC ULTRA®MEDTRONIC, INC.305U272014-09-23
00885074253275MOSAIC ULTRA®MEDTRONIC, INC.305U292014-09-23
00885074253305MOSAIC ULTRA®MEDTRONIC, INC.305U232014-09-23
00721902316142FREESTYLE®MEDTRONIC, INC.995MS192014-09-23
00721902316159FREESTYLE®MEDTRONIC, INC.995MS212014-09-23
00721902316166FREESTYLE®MEDTRONIC, INC.995MS232014-09-23
00721902316173FREESTYLE®MEDTRONIC, INC.995MS252014-09-23
00721902316180FREESTYLE®MEDTRONIC, INC.995MS272014-09-23
00721902316197FREESTYLE®MEDTRONIC, INC.995MS292014-09-23
00721902694721MOSAIC®MEDTRONIC, INC.305C192014-09-23
00721902694738MOSAIC®MEDTRONIC, INC.305C212014-09-23
00721902694745MOSAIC®MEDTRONIC, INC.305C232014-09-23
00721902694752MOSAIC®MEDTRONIC, INC.305C252014-09-23
00721902694769MOSAIC®MEDTRONIC, INC.305C272014-09-23
00721902694776MOSAIC®MEDTRONIC, INC.305C292014-09-23
00681490219037FREESTYLE®MEDTRONIC, INC.995CS192014-09-23
00681490219075FREESTYLE®MEDTRONIC, INC.995CS212014-09-23
00681490219112FREESTYLE®MEDTRONIC, INC.995CS232014-09-23
00681490219150FREESTYLE®MEDTRONIC, INC.995CS252014-09-23
00681490219198FREESTYLE®MEDTRONIC, INC.995CS272014-09-23
00681490265898FREESTYLE®MEDTRONIC, INC.FR995-212014-09-23
00681490265904FREESTYLE®MEDTRONIC, INC.FR995-232014-09-23
00681490265942FREESTYLE®MEDTRONIC, INC.FR995-272014-09-23
00681490816465FREESTYLE®MEDTRONIC, INC.FR995-292014-09-23
00690103021516CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC26252014-08-30
00690103021523CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC26252014-08-30
00690103021530CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC26252014-08-30
00690103021547CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC26252014-08-30
00690103021554CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC26252014-08-30
00690103021561CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC26252014-08-30
00690103021578CARPENTIER-EDWARDS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC26252014-08-30
00690103021585CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC27002014-08-30
00690103021592CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC27002014-08-30
00690103021608CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC27002014-08-30
00690103021615CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC27002014-08-30
00690103021622CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC27002014-08-30
00690103021639CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC27002014-08-30
00690103021646CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC28002014-08-30
00690103021653CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC28002014-08-30
00690103021660CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC28002014-08-30
00690103021677CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC28002014-08-30
00690103021684CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC28002014-08-30
00690103021691CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTICEdwards Lifesciences LLC28002014-08-30
00690103144116EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2500P2014-08-30
00690103144123EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2500P2014-08-30
00690103144130EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS - AORTICEdwards Lifesciences LLC2500P2014-08-30