FDA.reportPublic FDA data

SAPIEN M3 Transcatheter Heart Valve

Primary DI
00690103219753
Brand
SAPIEN M3 Transcatheter Heart Valve
Company
Edwards Lifesciences LLC
Model
9880TFX29M
Catalog number
9880TFX29MA
Device description
SAPIEN M3 Transcatheter Heart Valve
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
P250019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250019000SAPIEN M3 Transcatheter Mitral Valve Replacement SystemEdwards Lifesciences, LLC2025-12-22NPU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103219753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103219753006901032197536901032197530690103219753

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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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
05415067032676Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29