Vietnam MOH registration 2300669ĐKLH/BYT-HTTB
Even though the oval pore is sealed
VN: Dù đóng lỗ bầu dục
Vietnam·Risk Class TTBYT Loại D·Amplatzer Talisman PFO Occluder·Abbott Medical·Registered Aug 17, 2023Registration details
- Analysis ID
- 2300669ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220307-0032
- Product Type
- Amplatzer Talisman PFO Occluder
- Product Code
- 9-PFO-1818; 9-PFO-2518; 9-PFO-3025; 9-PFO-3525.
Company information
- Manufacturer
- Abbott Medical
- Manufacturer Country
- UNITED STATES
Technical details
- Intended Use
- The PFO Amplatzer Talisman is a percutaneous transluminal device designed to close the patent foramen ovale (PFO). The PFO Amplatzer Talisman is indicated for the closure of the PFO across the skin to reduce the risk of recurrent ischemic stroke in patients who are suspected of having suffered a stroke due to a cryptogenic thrombosis.
Dates and status
- Registration Date
- Aug 17, 2023
About this record
Access comprehensive regulatory information for Even though the oval pore is sealed 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 2300669ĐKLH/BYT-HTTB and manufactured by Abbott Medical.
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