ALTRUA™ 2 SR

GUDID 00802526559327

Pacemaker

BOSTON SCIENTIFIC CORPORATION

Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00802526559327
• NIH Device Record Key: b4b8f5cf-58ea-4dff-a864-a1cbfef332ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALTRUA™ 2 SR
• Version Model Number: S701
• 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	00802526559327 [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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2014-11-11

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729042549 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729042570 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042587 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042594 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042600 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729154921 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729154969 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729191872 - Passport: 2024-04-05 Balloon Dilatation Catheter