FDA.reportPublic FDA data

Tendyne™

Primary DI
05415067032522
Brand
Tendyne™
Company
ST. JUDE MEDICAL, INC.
Model
TENDV-SP-37M
Catalog number
TENDV-SP-37M
Device description
Mitral Valve
Published
2025-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPUProsthesis, mitral valve, percutaneously delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPUProsthesis, Mitral Valve, Percutaneously DeliveredUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240042000Tendyne Transcatheter Mitral Valve SystemABBOTT MEDICAL2025-05-23NPU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067032522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067032522054150670325225415067032522

GMDN Terms#

Term, Definition table
TermDefinition
Mitral transcatheter heart valve bioprosthesisAn implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant mitral heart valve, or previously-implanted mitral heart valve prosthesis, and which is implanted with a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter37Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius47 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit116 Degrees Fahrenheit
Storage Environment Temperature5 Degrees Celsius47 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit116 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
00690103219753SAPIEN M3 Transcatheter Heart ValveEdwards Lifesciences LLCNPU2026-01-30
00690103219760SAPIEN M3 Dock Steerable CatheterEdwards Lifesciences LLCNPU2026-01-30
00690103219777Edwards Commander M Delivery SystemEdwards Lifesciences LLCNPU2026-01-30
00690103219784Edwards 23F Guide SheathEdwards Lifesciences LLCNPU2026-01-30
00690103219791SAPIEN M3 CrimperEdwards Lifesciences LLCNPU2026-01-30
05415067032027Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032096Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032447Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032454Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032461Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032478Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032485Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032492Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032508Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032515Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032539Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032546Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032553Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032560Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032577Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032584Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032591Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032607Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032614Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032621Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032638Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032645Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032652Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032669Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29
05415067032676Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29