FDA.reportPublic FDA data

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)

Primary DI
00690103192087
Brand
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)
Company
Edwards Lifesciences LLC
Model
9300TFX
Catalog number
9300TFX26A
Device description
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (26MM)
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
00690103192087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103192087006901031920876901031920870690103192087

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary transcatheter heart valve bioprosthesisA sterile implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be 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
00690103220636ESHEATH OPTIMA14000ES16A14000ES162025-10-09
00690103219784Edwards 23F Guide Sheath9880GS9880GSA2026-01-30
00690103219562Edwards EVOQUE Loading System9850LSB9850LSBUS2025-07-09
00690103219579Edwards EVOQUE Stabilizer9850SZUS9850SZUS2025-07-09
00690103220629ESHEATH OPTIMA INTRODUCER SET (14F)14000ES1414000ES142025-05-07
00690103217773Edwards EVOQUE Loading System9850LSAUS9850LSAUS2024-10-03
00690103217483EVOQUE9850PTUS9850PTUS2024-02-07
00690103217490EVOQUE9850LSUS9850LSUS2024-02-07
00690103217506EVOQUE9850DKUS9850DKUS2024-02-07
00690103217513EVOQUE9850SBUS9850SBUS2024-02-07
00690103217476EVOQUE9850BAUS9850BAUS2024-02-06
00690103215465Edwards eSheath+ Introducer set914ESP914ESPA2021-10-06
00690103215472Edwards eSheath+ Introducer set916ESP916ESPA2021-10-06
00690103182262EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T262015-09-24
00690103182279EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T282015-09-24
00690103182286EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T302015-09-24
00690103182293EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T322015-09-24
00690103182309EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T342015-09-24
00690103182316EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T362015-09-24
00690103190816Thruport Systems Introducer Sheath KitIS19AIS19A2016-08-31

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