FDA.reportPublic FDA data

TRIFORMIS RESILIA Tricuspid Valve

Primary DI
00690103220261
Brand
TRIFORMIS RESILIA Tricuspid Valve
Company
Edwards Lifesciences LLC
Model
11300T33
Catalog number
11300T33
Device description
RESILIA Tricuspid Valve, size 33 mm
Published
2026-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWRHeart-Valve, Non-Allograft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWRHeart-Valve, Non-Allograft TissueUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150048094

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150048094EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)Edwards Lifesciences, LLC2017-06-29LWR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103220261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103220261006901032202616901032202610690103220261

GMDN Terms#

Term, Definition table
TermDefinition
Tricuspid open-surgery heart valve bioprosthesisA 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 tricuspid 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 Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00690103019810HEART VALVE ACCESSORY1175T1175T302026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103220223TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
08022057014696PERCEVALCORCYM SRLLWR2025-05-09
08022057014702PERCEVALCORCYM SRLLWR2025-05-09
08022057014719PERCEVALCORCYM SRLLWR2025-05-09
08022057014726PERCEVALCORCYM SRLLWR2025-05-09
08022057015365PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015372PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015389PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015396PERCEVAL PLUSCORCYM SRLLWR2025-05-07
00763000926489Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926496Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926502Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926519Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926526Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000647025Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647032Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647049Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647056Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647063Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647070Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
05415067045447Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045454Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045461Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045478Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
08022057015532Perceval RELYON PAK CORCYM SRLLWR2022-11-11
08022057015549Perceval RELYON PAK CORCYM SRLLWR2022-11-11
08022057015556Perceval RELYON PAK CORCYM SRLLWR2022-11-11