ALTRUA™ 20

GUDID 00802526484384

Pacemaker

BOSTON SCIENTIFIC CORPORATION

Single-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00802526484384
• NIH Device Record Key: 31d84555-8fe4-4f6c-99d9-2f4d6fe65e20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALTRUA™ 20
• Version Model Number: S201
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00802526484384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N970003

FDA Product Code

• LWP: Implantable pulse generator, pacemaker (non-CRT)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [ALTRUA™ 20]

• 00802526499210: Pacemaker
• 00802526499128: Pacemaker
• 00802526484421: Pacemaker
• 00802526484391: Pacemaker
• 00802526484384: Pacemaker