WATCHMAN FLX™ Pro M635WU60400

GUDID 00191506004637

Left Atrial Appendage Closure Device with Delivery System

BOSTON SCIENTIFIC CORPORATION

Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder

• Primary Device ID: 00191506004637
• NIH Device Record Key: a733804c-c409-41b9-b4ad-fdb71a382d6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WATCHMAN FLX™ Pro
• Version Model Number: M635WU60400
• Catalog Number: M635WU60400
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: false
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506004637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130013

FDA Product Code

• NGV: System, appendage closure, left atrial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-12
• Device Publish Date: 2023-09-12

On-Brand Devices [WATCHMAN FLX™ Pro]

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• 00191506004606: Left Atrial Appendage Closure Device with Delivery System
• 00191506004590: Left Atrial Appendage Closure Device with Delivery System
• 00191506004583: Left Atrial Appendage Closure Device with Delivery System