SAPIEN 3 Ultra RESILIA 9755RSL26A

GUDID 00690103215816

SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 26mm

Edwards Lifesciences LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework

• Primary Device ID: 00690103215816
• NIH Device Record Key: f81c6229-d56e-49cf-a2f6-4f4f7b38196e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAPIEN 3 Ultra RESILIA
• Version Model Number: 9755RSL26
• Catalog Number: 9755RSL26A
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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
• 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 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze. Store between 10 and 25 Celsius Degrees (50 to 77 Fahrenheit degrees)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103215816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140031

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: 2022-09-02
• Device Publish Date: 2022-08-25

On-Brand Devices [SAPIEN 3 Ultra RESILIA ]

• 00690103215823: SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 29mm
• 00690103215816: SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 26mm
• 00690103215809: SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 23mm
• 00690103215793: SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 20mm