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Product Classification

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Device

pulmonic valved conduit

Review Panel

Cardiovascular

Product Code

MWH

Submission Type

HDE

Device Class

3 (De Novo Petitions Granted)

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

AAMI/ANSI/ISO 5840:2005/(R)2010 Cardiovascular implants - Cardiac valve prostheses
ISO 5840 Fourth edition 2005-03-01 Cardiovascular implants - Cardiac valve prostheses

Third Party Review

Not Third Party Eligible

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