ACCOLADE™ MRI EL DR

GUDID 00802526559266

Pacemaker

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00802526559266
• NIH Device Record Key: e026c323-e09c-4f5e-9461-4d97fbc54c86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCOLADE™ MRI EL DR
• Version Model Number: L331
• 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	00802526559266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150012

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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-05-10

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 00191506055752 - IceSeed™: 2025-02-27 Cryoablation Needle
• 00191506055769 - IceSphere™: 2025-02-27 Cryoablation Needle
• 00191506055776 - IceRod™: 2025-02-27 Cryoablation Needle
• 00191506060138 - OverStitch™: 2025-02-25 Polypropylene Suture
• 00191506049157 - X-Tack™: 2025-02-25 Endoscopic HeliX Tacking System (Gastric)
• 00191506049164 - X-Tack™: 2025-02-25 Endoscopic HeliX Tacking System (Colonic)
• 00191506049188 - NA: 2025-02-25 Suture Cinch - Long
• 00191506060046 - OverStitch™: 2025-02-25 Suture Cinch