FDA.reportPublic FDA data

Avalus™

Primary DI
00643169983229
Brand
Avalus™
Company
MEDTRONIC, INC.
Model
40029
Device description
VALVE 40029 AVALUS AOR MMX U30 US
Published
2024-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYEreplacement Heart-valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYEReplacement Heart-ValveCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170006024

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170006024AVALUS(TM) BIOPROSTHESISMedtronic, Inc.2017-07-31LWR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169983229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169983229006431699832296431699832290643169983229

GMDN Terms#

Term, Definition table
TermDefinition
Aortic heart valve bioprosthesisA xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000990558Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
00763000990565Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
00763000990572Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
00763000990589Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
00763000990596Mosaic Neo™ 310MEDTRONIC, INC.DYE2026-04-13
00763000926465Hancock™ 150MEDTRONIC, INC.DYE2024-07-22
00763000926472Hancock™ 150MEDTRONIC, INC.DYE2024-07-22
00690103194074CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTICEdwards Lifesciences LLCDYE2019-11-27
00690103194081CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTICEdwards Lifesciences LLCDYE2019-11-27
00690103194098CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLCDYE2019-11-27
00690103194104CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLCDYE2019-11-27
00690103194128CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESISEdwards Lifesciences LLCDYE2019-08-09
00690103194012CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194029CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194036CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194043CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194050CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00690103194067CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisEdwards Lifesciences LLCDYE2019-02-21
00643169646483Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646490Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646506Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646513Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646520Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646537Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646544Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646551Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169646568Hancock™MEDTRONIC, INC.DYE2016-12-12
00643169594241HANCOCK® IIMEDTRONIC, INC.DYE2015-10-08
00643169594258HANCOCK® IIMEDTRONIC, INC.DYE2015-10-07
00643169594265HANCOCK® IIMEDTRONIC, INC.DYE2015-10-07