THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM 29AP4045A

GUDID 00690103210866

ALTERRA ADAPTIVE PRESTENT SYSTEM (US) 40MM X 48MM

Edwards Lifesciences LLC

Pulmonary transcatheter heart valve bioprosthesis

• Primary Device ID: 00690103210866
• NIH Device Record Key: 3241c6d4-749c-45b7-94dd-d6c60fe5fb68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM
• Version Model Number: 29AP4045
• Catalog Number: 29AP4045A
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00690103210866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200015

FDA Product Code

• NPV: Pulmonary Valve Prosthesis 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: 2021-12-31
• Device Publish Date: 2021-12-23

Devices Manufactured by Edwards Lifesciences LLC

• 00690103220629 - ESHEATH OPTIMA INTRODUCER SET (14F): 2025-05-15 eSheath Optima Introducer Set (14F)
• 00690103217957 - HemoSphere Alta: 2025-03-21 HemoSphere Alta advanced monitor (All-on-one)
• 00690103217964 - HemoSphere Alta: 2025-03-21 HemoSphere Alta advanced monitor (Smart Recovery)
• 00690103217971 - HemoSphere Alta: 2025-03-21 HemoSphere Alta monitor (Cardiac)
• 00690103217278 - Edwards: 2025-01-15 Edwards Reusable Plate
• 00690103217292 - Edwards: 2025-01-15 Edwards Reusable Platform
• 00690103218015 - Edwards: 2025-01-15 Edwards Reusable Cradle
• 00690103019063 - HEART VALVE HANDLE ACCESSORY: 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV