FDA.reportPublic FDA data

Navitor Titan™

Primary DI
05415067045768
Brand
Navitor Titan™
Company
ST. JUDE MEDICAL, INC.
Model
NVRO-35
Catalog number
NVRO-35
Device description
Transcatheter Heart Valve
Published
2023-09-29
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190023013

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190023013Portico Transcatheter Aortic Valve Implantation SystemABBOTT MEDICAL2021-09-17NPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067045768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067045768054150670457685415067045768

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
Outer Diameter35Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius25 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

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