SAPIEN 3 Ultra System 9750CM23A

GUDID 00690103207828

SAPIEN 3 Ultra valve with Commander delivery System

Edwards Lifesciences LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework

• Primary Device ID: 00690103207828
• NIH Device Record Key: f792b4d5-ca30-4727-9ead-08a37a2e6f33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAPIEN 3 Ultra System
• Version Model Number: 9750CM23
• Catalog Number: 9750CM23A
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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
• 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
• 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
• 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

• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter
• Outer Diameter: 23 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *The delivery system should be stored in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103207828 [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: 2019-09-09
• Device Publish Date: 2019-08-30

On-Brand Devices [SAPIEN 3 Ultra System ]

• 00690103207835: SAPIEN 3 Ultra valve with Commander Delivery System
• 00690103207828: SAPIEN 3 Ultra valve with Commander delivery System
• 00690103207811: SAPIEN 3 Ultra valve with Commander Delivery System