WATCHMAN FLX™ Pro M635WU60400

GUDID 00191506004637

Left Atrial Appendage Closure Device with Delivery System

BOSTON SCIENTIFIC CORPORATION

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]

• 00191506004637: Left Atrial Appendage Closure Device with Delivery System
• 00191506004620: Left Atrial Appendage Closure Device with Delivery System
• 00191506004613: Left Atrial Appendage Closure Device with Delivery System
• 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