FDA.reportPublic FDA data

3f®

Primary DI
00613994961587
Brand
3f®
Company
MEDTRONIC 3F THERAPEUTICS, INC.
Model
1000-29
Device description
THV 1000-29 3F AORTIC BIO 29MM 2PC HLDR
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWRheart-valve, non-allograft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWRHeart-Valve, Non-Allograft TissueUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060025000ATS 3F AORTIC BIOPROSTHESISMedtronic, Inc.2008-10-30LWR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994961587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994961587006139949615876139949615870613994961587

GMDN Terms#

Term, Definition table
TermDefinition
Aortic heart valve bioprosthesisA sterile 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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
079527232
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
006139949597203f®1000-292014-09-23
006139949615943f®1000-272014-09-23
006139949616003f®1000-252014-09-23
006139949616173f®1000-232014-09-23
006139949616243f®1000-212014-09-23
006431690725033f®1000-212014-09-23
006431690725103f®1000-232014-09-23
006431690725273f®1000-252014-09-23
006431690725343f®1000-272014-09-23
006431690725413f®1000-292014-09-23
006431690725583f®1000-292014-09-23
006139948682133f®1000-292014-09-23
006139948682203f®1000-212014-09-23
006139948682373f®1000-232014-09-23
006139948682443f®1000-252014-09-23
006139948682513f®1000-272014-09-23
006139948682683f®1000-292014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00690103220230TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid ValveEdwards Lifesciences LLCLWR2026-05-28
08022057014696PERCEVALCORCYM SRLLWR2025-05-09
08022057014702PERCEVALCORCYM SRLLWR2025-05-09
08022057014719PERCEVALCORCYM SRLLWR2025-05-09
08022057014726PERCEVALCORCYM SRLLWR2025-05-09
08022057015365PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015372PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015389PERCEVAL PLUSCORCYM SRLLWR2025-05-07
08022057015396PERCEVAL PLUSCORCYM SRLLWR2025-05-07
00763000926489Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926496Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926502Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926519Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000926526Hancock™ 150MEDTRONIC, INC.LWR2024-07-22
00763000647025Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647032Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647049Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647056Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647063Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
00763000647070Avalus Ultra™MEDTRONIC, INC.LWR2024-05-04
05415067045447Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045454Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045461Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
05415067045478Epic™ST. JUDE MEDICAL, INC.LWR2023-08-01
08022057015532Perceval RELYON PAK CORCYM SRLLWR2022-11-11
08022057015549Perceval RELYON PAK CORCYM SRLLWR2022-11-11