FDA.reportPublic FDA data

Trilogy Transcatheter Heart Valve

Primary DI
00850000898219
Brand
Trilogy Transcatheter Heart Valve
Company
Jenavalve Technology, Inc.
Model
TRILOGY-THV-M
Catalog number
TRILOGY-THV-M
Device description
Pericardial THV Size 25MM
Published
2026-03-25
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
NPTAortic Valve, Prosthesis, Percutaneously Delivered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000898219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000898219008500008982198500008982190850000898219

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, Specify00These devices must be stored in a cool, dry place. Store the valve (THV) in the upright position. The THV must be stored between 2°C (36°F) and 25°C (77°F).

Contacts#

Phone, Email table
PhoneEmail
+1-866-588-8287CustomerSupport.US@jenavalve.com

Regulatory Flags#

DUNS number
827951620
Device count
1
HCT/P
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000898103Trilogy Transcatheter Heart ValveTRILOGY-THV-STRILOGY-THV-S2026-03-25
00850000898110Trilogy Transcatheter Heart ValveTRILOGY-THV-MTRILOGY-THV-M2026-03-25
00850000898127Trilogy Transcatheter Heart ValveTRILOGY-THV-LTRILOGY-THV-L2026-03-25
00850000898134Trilogy Delivery CatheterTRILOGY-DC-STRILOGY-DC-S2026-03-25
00850000898141Trilogy Delivery CatheterTRILOGY-DC-MTRILOGY-DC-M2026-03-25
00850000898158Trilogy Delivery CatheterTRILOGY-DC-LTRILOGY-DC-L2026-03-25
00850000898165Trilogy Loading ToolsTRILOGY-LT-STRILOGY-LT-S2026-03-25
00850000898172Trilogy Loading ToolsTRILOGY-LT-MTRILOGY-LT-M2026-03-25
00850000898189Trilogy Loading ToolsTRILOGY-LT-LTRILOGY-LT-L2026-03-25
00850000898196Trilogy Introducer SheathTRILOGY-INTTRILOGY-INT2026-03-25
00850000898202Trilogy Transcatheter Heart ValveTRILOGY-THV-STRILOGY-THV-S2026-03-25
00850000898226Trilogy Transcatheter Heart ValveTRILOGY-THV-LTRILOGY-THV-L2026-03-25

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
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
00763000716158Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
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