Product Code: LWR


Products Classified as LWR

1014Heart-valve, Non-allograft Tissue

Total Product Life Cycle (TPLC) Devices

1014Heart-valve, Non-allograft Tissue

FDA Consensus Standards

Heart-Valve, Non-Allograft Tissue [36801]21 CFR Unclassified 🔎
Heart-Valve, Non-Allograft Tissue [36800]21 CFR Unclassified 🔎

Pre-market Approvals for LWR

P990064MOSAIC PORCINE BIOPROSTHESISMedtronic, Inc.
P0600253F AORTIC BIOPROSTHESISMEDTRONIC Inc.
P060038Mitroflow Aortic Pericardial Heart ValveLivaNova Canada Corp.
P150011Perceval Heart ValveLivaNova Canada Corp.
P040021Biocor Valve, Supra Valve; Epic Valve, SupraSt. Jude Medical, Inc.
P970031Freestyle Aortic Root BioprosthesisMedtronic, Inc.
P170006Avalus BioprosthesisMedtronic Inc.
P790007Hancock Valved Conduit LPMEDTRONIC HEART VALVES
P150036EDWARDS INTUITY Elite Valve SystemEDWARDS LIFESCIENCES, LLC.
P150048Edwards Pericardial Aortic BioprosthesisEDWARDS LIFESCIENCES, LLC.
P100029Trifecta/Trifecta GT ValvesSt. Jude Medical, Inc.
P130011Solo Smart Heart ValveLivaNova Canada Corp.

Global Unique Device Identification Database

00613994868268heart-valve, non-allograft tissue
00613994868251heart-valve, non-allograft tissue
00613994868244heart-valve, non-allograft tissue
00613994868237heart-valve, non-allograft tissue
00613994868220heart-valve, non-allograft tissue
00613994868213heart-valve, non-allograft tissue
00613994772732heart-valve, non-allograft tissue
00613994772725heart-valve, non-allograft tissue
00613994772718heart-valve, non-allograft tissue
00613994760760heart-valve, non-allograft tissue
00613994760746heart-valve, non-allograft tissue
00613994760739heart-valve, non-allograft tissue
00613994760722heart-valve, non-allograft tissue
00613994760715heart-valve, non-allograft tissue
00613994760708heart-valve, non-allograft tissue

Maude Adverse Events

EPIC SUPRA VALVE W/FLEXFITST. JUDE MEDICAL, COSTA RICA LTDA (CVD)2020-03-31
FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRONIC HEART VALVES DIVISION2020-03-31
EDWARDS INTUITY ELITE VALVE SYSTEMEDWARDS LIFESCIENCES2020-03-31
EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEMST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA)2020-03-31
SJM TRIFECTA VALVEST. JUDE MEDICAL, COSTA RICA LTDA (CVD)2020-03-30
EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEMST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA)2020-03-30
TRIFECTA? GT VALVEST. JUDE MEDICAL, COSTA RICA LTDA (CVD)2020-03-30
EDWARDS INTUITY ELITE VALVE SYSTEMEDWARDS LIFESCIENCES2020-03-30
FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRONIC HEART VALVES DIVISION2020-03-30
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP2020-03-26
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP2020-03-26
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP2020-03-26
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP2020-03-26
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP2020-03-26
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP2020-03-26
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVEMEDTRONIC HEART VALVE DIVISION2020-03-26
SJM TRIFECTA VALVEST. JUDE MEDICAL, BRASIL LTDA.2020-03-26
HANCOCK AORTIC BIOPROSTHETIC HEART VALVEMEDTRONIC HEART VALVES DIVISION2020-03-25
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVEMEDTRONIC HEART VALVES DIVISION2020-03-25
EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEMST. JUDE MEDICAL, COSTA RICA LTDA (CVD)2020-03-25
EDWARDS INSPIRIS RESILIA AORTIC VALVEEDWARDS LIFESCIENCES2020-03-24
EDWARDS INTUITY ELITE VALVE SYSTEMEDWARDS LIFESCIENCES2020-03-24
FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRONIC HEART VALVES DIVISION2020-03-24
INSPIRIS RESILIA AORTIC VALVEEDWARDS LIFESCIENCES2020-03-24
EDWARDS INTUITY ELITE VALVE SYSTEMEDWARDS LIFESCIENCES2020-03-24
FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRONIC HEART VALVES DIVISION2020-03-24
MOSAIC AORTIC BIOPROSTHETIC HEART VALVEMEDTRONIC HEART VALVES DIVISION2020-03-24
SJM TRIFECTA VALVEST. JUDE MEDICAL, COSTA RICA LTDA (CVD)2020-03-24
TRIFECTA? GT VALVEST. JUDE MEDICAL, COSTA RICA LTDA2020-03-23
SJM TRIFECTA VALVEST. JUDE MEDICAL, COSTA RICA LTDA (CVD)2020-03-23
FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRONIC HEART VALVES DIVISION2020-03-23
EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEMST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA)2020-03-23
MOSAIC PORCINE HEART VALVEMEDTRONIC HEART VALVE DIVISION2020-03-21
FREESTYLEMEDTRONIC HEART VALVES DIVISION2020-03-21
FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRONIC HEART VALVES DIVISION2020-03-21
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP.2020-03-20
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP.2020-03-20
FREESTYLE AORTIC ROOT BIOPROSTHESISMEDTRONIC HEART VALVE DIVISION2020-03-20
EDWARDS INSPIRIS RESILIA AORTIC VALVEEDWARDS LIFESCIENCES2020-03-19
HANCOCK II MITRAL BIOPROSTHETIC HEART VALVEMEDTRONIC HEART VALVES DIVISION2020-03-19
INSPIRIS RESILIA AORTIC VALVEEDWARDS LIFESCIENCES2020-03-19
TRIFECTA? GT VALVEST. JUDE MEDICAL, COSTA RICA LTDA2020-03-19
SJM TRIFECTA VALVEST. JUDE MEDICAL, BRASIL LTDA.2020-03-19
TRIFECTA? GT VALVEST. JUDE MEDICAL, COSTA RICA LTDA (CVD)2020-03-19
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP2020-03-19
PERCEVAL SUTURELESS AORTIC HEART VALVELIVANOVA CANADA CORP2020-03-19
SJM TRIFECTA VALVEST. JUDE MEDICAL CATD2020-03-19
TRIFECTA STENTED TISSUE VALVEST. JUDE MEDICAL CATD2020-03-19
EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEMST. JUDE MEDICAL, BRASIL LTDA.2020-03-18
TRIFECTA? GT VALVEST. JUDE MEDICAL, BRASIL LTDA.2020-03-18
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