Product Classification

• Device: pacemaker lead adaptor
• Regulation Description: Pacemaker lead adaptor.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DTD
• Submission Type: 510(k)
• Regulation Number: 870.3620
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 5841-3 Second edition 2000-10-15 Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers

Third Party Review

Not Third Party Eligible