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

• 50690103000073 - CO-SET INJECTATE ICE BUCKET: 2025-07-24 CO-SET INJECTATE ICE BUCKET 6 PER CASE
• 00690103002546 - CLAMP FOR DPT HOLDER: 2025-07-23 PRESSURE MONITORING ACCESSORY
• 50690103197902 - TRUCLIP: 2025-07-23 TRUCLIP
• 50690103210823 - Combo Kits: 2025-07-23 Pressure Monitoring Set
• 00690103216998 - HEMOSPHERE: 2025-07-23 Mindray OEM Pressure Smart Cable
• 00690103219111 - Cable: 2025-07-23 PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE
• 07460691949867 - PRESSURE MONITORING ACCESSORY: 2025-07-23 PRESSURE MONITORING ACCESSORY
• 57460691956143 - TruWave: 2025-07-23 PRESSURE MONITORING ACCESSORY