FORMIO™

GUDID 00802526517259

Pacemaker

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00802526517259
• NIH Device Record Key: 02bab921-9466-4990-8691-ea690e5c4366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORMIO™
• Version Model Number: K278
• 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	00802526517259 [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: 4
• Public Version Date: 2018-12-11
• Device Publish Date: 2014-09-24

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