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Tissue expander system - Skin expander

Access comprehensive regulatory information for Tissue expander system - Skin expander in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Allied Scientific Products Pty Ltd, manufactured by PMT Corporation in United States of America. The device registration started on June 02, 2020.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
Class IIb
Tissue expander system - Skin expander
Australia TGA ARTG Registered Device
Good Name: Allied Scientific Products Pty Ltd - Tissue expander system - Skin expander
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Intended Purpose

A sterile, inflatable device implanted temporarily to enlarge the dimensions of a skin flap for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope, with fill tube, an inflation valve, and a needle. This device is not intended to be used in the breast. This is a single-use device.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
June 02, 2020
Effective Date
June 02, 2020
Manufacturer
Country
United States of America
Address
1500 Park Road, CHANHASSEN, MN, 55317