FDA.reportPublic FDA data

CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC

Primary DI
00690103177237
Brand
CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC
Company
Edwards Lifesciences LLC
Model
2800TFX
Catalog number
2800TFX21MM
Published
2014-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYEreplacement Heart-valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYEReplacement Heart-ValveCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P860057001
P860057004
P860057019
P860057022
P860057023
P860057030
P860057036
P860057039
P860057045
P860057051
P860057053
P860057062
P860057100

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P860057001EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057004EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057019EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057022EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057023EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057030EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057036EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057039EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057045EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057051EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057053EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057062EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE
P860057100EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESEdwards Lifesciences, LLC1991-09-26DYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103177237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103177237006901031772376901031772370690103177237

GMDN Terms#

Term, Definition table
TermDefinition
Aortic heart valve bioprosthesisA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9837tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00690103194043CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194050CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194067CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
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