Vietnam MOH registration 2300670ĐKLH/BYT-HTTB

Device for supporting the deployment of the parachute to close the oval hole

VN: Dụng cụ hỗ trợ bung Dù đóng lỗ bầu dục

Vietnam·Risk Class TTBYT Loại D·Amplatzer Talisman Delivery Sheath·Abbott Medical·Registered Aug 17, 2023

Registration details

Analysis ID: 2300670ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220308-0029
Product Type: Amplatzer Talisman Delivery Sheath
Product Code: 9-TDS-08F45-80, 9-TDS-09F45-80

Company information

Manufacturer: Abbott Medical
Manufacturer Country: UNITED STATES

Technical details

Intended Use: Purpose: The Amplatzer Talisman Delivery Sheath is designed to facilitate the delivery and deployment of the PFO Amplatzer closure umbrella. Indications: The Amplatzer Talisman Delivery Sheath is indicated for patients who are recommended to undergo closure of the patent foramen ovale (PFO) using the PFO Amplatzer closure umbrella.

Dates and status

Registration Date: Aug 17, 2023

About this record

Access comprehensive regulatory information for Device for supporting the deployment of the parachute to close the oval hole in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2300670ĐKLH/BYT-HTTB and manufactured by Abbott Medical.

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