SAPIEN M3 Transcatheter Heart Valve 9880TFX29MA

GUDID 00690103219753

SAPIEN M3 Transcatheter Heart Valve

Edwards Lifesciences LLC

Mitral transcatheter heart valve bioprosthesis

• Primary Device ID: 00690103219753
• NIH Device Record Key: 2e7de3a6-f57d-40e5-9a98-94e5c96f9597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAPIEN M3 Transcatheter Heart Valve
• Version Model Number: 9880TFX29M
• Catalog Number: 9880TFX29MA
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)
• Special Storage Condition, Specify: Between 0 and 0 *The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)
• Special Storage Condition, Specify: Between 0 and 0 *The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)
• Special Storage Condition, Specify: Between 0 and 0 *The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)
• Special Storage Condition, Specify: Between 0 and 0 *The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)
• Special Storage Condition, Specify: Between 0 and 0 *The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)
• Special Storage Condition, Specify: Between 0 and 0 *The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)
• Special Storage Condition, Specify: Between 0 and 0 *The SAPIEN M3 valve must be stored between 10° and 25° C (50° to 77° F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103219753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P250019

FDA Product Code

• NPU: Prosthesis, Mitral Valve, Percutaneously Delivered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-30

Devices Manufactured by Edwards Lifesciences LLC

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• 00690103221329 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 23 mm (Gen 2) (US)
• 00690103221336 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 26 mm (Gen 2) (US)
• 00690103221343 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 29 mm (Gen 2) (US)
• 00690103019353 - AORTIC TRUE-SIZE OBTURATOR 19MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019360 - AORTIC TRUE-SIZE OBTURATOR 21MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019377 - AORTIC TRUE-SIZE OBTURATOR 23MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019384 - AORTIC TRUE-SIZE OBTURATOR 25MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE