FDA.reportPublic FDA data

Tendyne™

Primary DI
05415067032676
Brand
Tendyne™
Company
ST. JUDE MEDICAL, INC.
Model
TENDV-SPAD
Catalog number
TENDV-SPAD
Device description
Apical Pad - Small
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
05415067032676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067032676054150670326765415067032676

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

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
05415067033307Amplatzer™ Talisman™9-PFO-18189-PFO-18182021-09-29
05415067033314Amplatzer™ Talisman™9-PFO-25189-PFO-25182021-09-29
05415067033321Amplatzer™ Talisman™9-PFO-30259-PFO-30252021-09-29
05415067033345Amplatzer™ Talisman™9-PFO-35259-PFO-35252021-09-29
00811806011103Amplatzer™9-PDA-0039-PDA-0032014-09-08
00811806011110Amplatzer™9-PDA-0049-PDA-0042014-09-08
00811806011127Amplatzer™9-PDA-0059-PDA-0052014-09-08
00811806011134Amplatzer™9-PDA-0069-PDA-0062014-09-08
00811806011141Amplatzer™9-PDA-0079-PDA-0072014-09-08
00811806011172Amplatzer™9-PDA2-03-049-PDA2-03-042014-09-08
00811806011189Amplatzer™9-PDA2-03-069-PDA2-03-062014-09-19
00811806011202Amplatzer™9-PDA2-04-049-PDA2-04-042014-09-15
00811806011219Amplatzer™9-PDA2-04-069-PDA2-04-062014-09-15
00811806011233Amplatzer™9-PDA2-05-049-PDA2-05-042014-09-15
00811806011240Amplatzer™9-PDA2-05-069-PDA2-05-062014-09-15
00811806011257Amplatzer™9-PDA2-06-049-PDA2-06-042014-09-15
00811806011264Amplatzer™9-PDA2-06-069-PDA2-06-062014-09-15
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16

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
05415067032522Tendyne™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