MOMENTUM™ X4 CRT-D

GUDID 00802526589188

Cardiac Resynchronization Therapy Defibrillator

BOSTON SCIENTIFIC CORPORATION

Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator

• Primary Device ID: 00802526589188
• NIH Device Record Key: a6724a6a-84e8-4061-9b05-d07fdc6f7a68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOMENTUM™ X4 CRT-D
• Version Model Number: G138
• Company DUNS: 106295384
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526589188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010012

FDA Product Code

• NIK: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-09
• Device Publish Date: 2017-09-27

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