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Product Classification

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Device

pulse-generator, program module

Review Panel

Cardiovascular

Product Code

LOT

Submission Type

PMA

Device Class

3

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standard

AAMI/ANSI PC69:2007 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators

Third Party Review

Not Third Party Eligible

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