FDA.reportPublic FDA data

EnVeo™ PRO

Primary DI
00643169987203
Brand
EnVeo™ PRO
Company
MEDTRONIC, INC.
Model
ENVPRO-14-US
Device description
18FR DELIV SYS ENVPRO-14-US
Published
2018-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
P130021043
P130021072
P130021083

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130021043MEDTRONIC COREVALVE SYSTEMMedtronic, Inc.2014-01-17NPT
P130021072MEDTRONIC COREVALVE SYSTEMMedtronic, Inc.2014-01-17NPT
P130021083MEDTRONIC COREVALVE SYSTEMMedtronic, Inc.2014-01-17NPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169987203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169987203006431699872036431699872030643169987203

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
Length107Centimeter
Outer Diameter6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the catheter and LS in a cool, dry environment.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

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
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