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 Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis 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

• 00690103216943 - PASCAL: 2022-09-27 PASCAL PRECISION SYSTEM – IMPLANT SYSTEM
• 00690103216950 - PASCAL: 2022-09-27 PASCAL PRECISION SYSTEM – PASCAL ACE IMPLANT SYSTEM
• 00690103216967 - PASCAL PRECISION: 2022-09-27 PASCAL PRECISION SYSTEM - GUIDE SHEATH
• 00690103216974 - PASCAL: 2022-09-27 PASCAL SYSTEM - STABILIZER RAIL SYSTEM
• 00690103216981 - PASCAL: 2022-09-27 PASCAL TABLE US COMMERCIAL
• 00690103215793 - SAPIEN 3 Ultra RESILIA: 2022-09-02 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 20mm
• 00690103215809 - SAPIEN 3 Ultra RESILIA: 2022-09-02 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 23mm
• 00690103215816 - SAPIEN 3 Ultra RESILIA: 2022-09-02 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, 26mm