FDA.reportPublic FDA data

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)

Primary DI
00690103193176
Brand
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)
Company
Edwards Lifesciences LLC
Model
9300TFX
Catalog number
9300TFX29A
Device description
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (29MM)
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
NPTAortic valve, prosthesis, percutaneously delivered
NPVPulmonary Valve Prosthesis Percutaneously Delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPTAortic Valve, Prosthesis, Percutaneously DeliveredUnknown3
NPVPulmonary Valve Prosthesis Percutaneously DeliveredUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130009000
P130009034
P130009037
P130009057

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130009000EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2014-06-16NPT
P130009034EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2014-06-16NPT
P130009037EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2014-06-16NPT
P130009057EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESEdwards Lifesciences, LLC2014-06-16NPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103193176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103193176006901031931766901031931760690103193176

GMDN Terms#

Term, Definition table
TermDefinition
Aortic transcatheter heart valve bioprosthesis, stent-like frameworkA sterile implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.

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
Serial number
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
00850000898103Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898110Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898127Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898134Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898141Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898158Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898165Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898172Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898189Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898196Trilogy Introducer SheathJenavalve Technology, Inc.NPT2026-03-25
00850000898202Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898219Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898226Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00690103221312Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00690103221343Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLCNPV2026-02-17
00763000942700Evolut™ FXMEDTRONIC COREVALVE LLCNPT2024-07-07
00763000942717Evolut™ FXMEDTRONIC COREVALVE LLCNPT2024-07-07
00763000942731Evolut™ FXMEDTRONIC COREVALVE LLCNPT2024-07-07
00763000942724Evolut™ FXMEDTRONIC COREVALVE LLCNPT2024-07-06
00763000716127Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
00763000716134Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
00763000716141Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
00763000716158Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
05415067045768Navitor Titan™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067045775Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067045782Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067045799Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067045805Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29