FDA.reportPublic FDA data

Edwards Commander M Delivery System

Primary DI
00690103219777
Brand
Edwards Commander M Delivery System
Company
Edwards Lifesciences LLC
Model
9880CM29A
Catalog number
9880CM29A
Device description
Edwards Commander M Delivery System
Published
2026-01-30
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
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
00690103219777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103219777006901032197776901032197770690103219777

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, Specify00Store in a cool dry place

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
Lot or batch
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
00690103219753SAPIEN M3 Transcatheter Heart ValveEdwards Lifesciences LLCNPU2026-01-30
00690103219760SAPIEN M3 Dock Steerable CatheterEdwards 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
05415067032676Tendyne™ST. JUDE MEDICAL, INC.NPU2025-05-29