Despite the closure of the oval recess
Vietnam·Risk Class TTBYT Loại D·Amplatzer PFO Occluder·Abbott Medical·Registered Feb 02, 2024- Analysis ID
- 2400073ĐKLH/BYT-HTTB
- Submission ID
- 19010566/ĐKLH-BYT-TB-CT
- Product Type
- Amplatzer PFO Occluder
- Product Code
- 9-PFO-018; 9-PFO-025; 9-PFO-035
- Manufacturer
- Abbott Medical
- Manufacturer Country
- UNITED STATES
- Product Owner
- Abbott Medical
- Authorized Representative
- CÔNG TY TNHH DƯỢC PHẨM VÀ TRANG THIẾT BỊ Y TẾ HOÀNG ĐỨC
- Intended Use
- The AMPLATZER™ PFO is a device intended for percutaneous closure of the heart's left atrium to occlude all types of PFO (including the classical type as well as those with a pouch on the septum) in patients with a history of stroke or acute stroke (TIAs) who are diagnosed with an echocardiogram and who undergo the Valsalva maneuver with a bidirectional catheter from right to left.
- Registration Date
- Feb 02, 2024
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Access comprehensive regulatory information for Despite the closure of the oval recess 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 2400073ĐKLH/BYT-HTTB and manufactured by Abbott Medical. The authorized representative in Vietnam is CÔNG TY TNHH DƯỢC PHẨM VÀ TRANG THIẾT BỊ Y TẾ HOÀNG ĐỨC.
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