EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) 9630PL29A

GUDID 00690103210873

SAPIEN 3 PULMONIC DELIVERY SYSTEM - 29MM (US)

Edwards Lifesciences LLC

Pulmonary transcatheter heart valve bioprosthesis

• Primary Device ID: 00690103210873
• NIH Device Record Key: d4e073af-1e81-427e-843f-fa58a34d7eff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM)
• Version Model Number: 9630PL29A
• Catalog Number: 9630PL29A
• 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)822-9637
• 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

• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 Millimeter
• Balloon Diameter: 29 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
• 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
• 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	00690103210873 [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: 2022-01-12
• Device Publish Date: 2022-01-04

Devices Manufactured by Edwards Lifesciences LLC

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• 50690103000417 - SWAN-GANZ: 2026-02-09 SWAN-GANZ THERMODILUTION CATHETER
• 00690103219753 - SAPIEN M3 Transcatheter Heart Valve: 2026-02-09 SAPIEN M3 Transcatheter Heart Valve
• 00690103219760 - SAPIEN M3 Dock Steerable Catheter: 2026-02-09 SAPIEN M3 Dock Steerable Catheter
• 00690103219777 - Edwards Commander M Delivery System: 2026-02-09 Edwards Commander M Delivery System
• 00690103219784 - Edwards 23F Guide Sheath: 2026-02-09 Edwards 23F Guide Sheath
• 00690103219791 - SAPIEN M3 Crimper: 2026-02-09 SAPIEN M3 Crimper
• 50690103000073 - CO-SET INJECTATE ICE BUCKET: 2025-07-24 CO-SET INJECTATE ICE BUCKET 6 PER CASE