FDA.reportPublic FDA data

Evolut™ FX+

Primary DI
00763000716158
Brand
Evolut™ FX+
Company
MEDTRONIC COREVALVE LLC
Model
EVFXPLUS-34
Device description
TAV EVFXPLUS-34 COMM US
Published
2024-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPTAortic valve, prosthesis, percutaneously delivered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130021155

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130021155MEDTRONIC COREVALVE SYSTEMMedtronic, Inc.2014-01-17NPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000716158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000716158007630007161587630007161580763000716158

GMDN Terms#

Term, Definition table
TermDefinition
Aortic transcatheter heart valve bioprosthesis, stent-like frameworkAn implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/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) or transapical access 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
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
079527231
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169954441CoreValve™ Evolut™ PROEVOLUTPRO-26-US2017-03-31
00643169954458CoreValve™ Evolut™ PROEVOLUTPRO-29-US2017-03-31
00763000942700Evolut™ FXD-EVOLUTFX-23292024-07-07
00763000942717Evolut™ FXD-EVOLUTFX-342024-07-07
00763000942724Evolut™ FXL-EVOLUTFX-23292024-07-06
00763000942731Evolut™ FXL-EVOLUTFX-342024-07-07
00763000716127Evolut™ FX+EVFXPLUS-232024-05-03
00763000716134Evolut™ FX+EVFXPLUS-262024-05-03
00763000716141Evolut™ FX+EVFXPLUS-292024-05-03
00763000207861Evolut™ PRO+D-EVPROP34US2019-10-04
00763000211110Evolut™ PRO+EVPROPLUS-26US2019-10-04
00643169430310CoreValve™ Evolut™MCS-P4-23-AOA2014-09-23
00643169448513CoreValve™ Evolut™MCS-P3-31-AOA-US2014-09-23
00643169448520CoreValve™ Evolut™MCS-P4-23-AOA-US2014-09-23
00643169448537CoreValve™ Evolut™MCS-P3-26-AOA-US2014-09-23
00643169448544CoreValve™ Evolut™MCS-P3-29-AOA-US2014-09-23
00643169448551CoreValve™ Evolut™MCS-P3-31-AOA-US2014-09-23
00643169565623CoreValve™DCS-C4-18F-US2015-08-06
00643169448162CoreValve™CLS-3000-18F-US2014-09-23
00643169448483CoreValve™ Evolut™MCS-P4-23-AOA-US2014-09-23

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
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
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
05415067048417Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067036650Navitor™ST. JUDE MEDICAL, INC.NPT2023-01-16
05415067036667Navitor™ST. JUDE MEDICAL, INC.NPT2023-01-16
05415067031570Navitor™ST. JUDE MEDICAL, INC.NPT2023-01-16
05415067031587Navitor™ST. JUDE MEDICAL, INC.NPT2023-01-16