Edwards SAPIEN 3 transcatheter pulmonic valve delivery system 9631PL20A

GUDID 00690103221312

Pulmonic Delivery System - 20 mm (Gen 2) (US)

Edwards Lifesciences LLC

Pulmonary transcatheter heart valve bioprosthesis

• Primary Device ID: 00690103221312
• NIH Device Record Key: 9d902d62-c53d-4136-9a85-c2ad9f75db61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards SAPIEN 3 transcatheter pulmonic valve delivery system
• Version Model Number: 9631PL20A
• Catalog Number: 9631PL20A
• 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: true
• 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)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com
• Phone: +1(800)822-9837
• Email: tech_support@edwards.com

Device Dimensions

• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103221312 [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: 2026-02-25
• Device Publish Date: 2026-02-17

On-Brand Devices [Edwards SAPIEN 3 transcatheter pulmonic valve delivery system]

• 00690103221343: Pulmonic Delivery System - 29 mm (Gen 2) (US)
• 00690103221336: Pulmonic Delivery System - 26 mm (Gen 2) (US)
• 00690103221329: Pulmonic Delivery System - 23 mm (Gen 2) (US)
• 00690103221312: Pulmonic Delivery System - 20 mm (Gen 2) (US)