FDA.reportPublic FDA data

INSPIRIS RESILIA AORTIC VALVE

Primary DI
00690103194999
Brand
INSPIRIS RESILIA AORTIC VALVE
Company
Edwards Lifesciences LLC
Model
11500A
Catalog number
11500A25
Device description
INSPIRIS RESILIA AORTIC VALVE
Published
2017-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
P150048000
P150048060

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150048000EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)Edwards Lifesciences, LLC2017-06-29LWR
P150048060EDWARDS 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
00690103194999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103194999006901031949996901031949990690103194999

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)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
00690103219500Edwards Reusable Rail10500RL10500RL2025-07-09
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067052742Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052759Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052766Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052780Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052797Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052803Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052810Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052827Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052834Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052858Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052865Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052872Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052889Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052896Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
05415067052902Epic™ST. JUDE MEDICAL, INC.LWR2026-07-08
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
00690103220261TRIFORMIS 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