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Product Classification

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Device

pulse-generator, single chamber, sensor driven, implantable

Review Panel

Cardiovascular

Product Code

LWO

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
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

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