Product Classification

• Device: implantable pulse generator, pacemaker (non-crt)
• Definition: These devices treat bradycardia (slow heartbeats) with ra and/or rv pacing therapy as necessary.
• Physical State: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
• Technical Method: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
• Target Area: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
• Review Panel: Cardiovascular
• Product Code: LWP
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI PC69:2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
• ISO 27186 First edition 2010-03-15 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
• AAMI/ANSI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
• AAMI TIR41:2011 Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
• 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