Mammoplasty Lift Bag
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Theo theo phụ lục·Registered Apr 18, 2023- Analysis ID
- 2300277ĐKLH/BYT-TB-CT
- Submission ID
- 17001075/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- This implant can be used for the following indications: • Aesthetic breast augmentation. The European Parliament "recommends that the implantation of breast implants in women under 18 years of age be permitted only for medical reasons". • Immediate or delayed breast reconstruction after mastectomy. • Breast reconstruction after cancer treatment, except in the case of mastectomy. • Correction of complications or other unwanted effects of previous breast surgery or cancer treatment, except in the case of mastectomy. • Post-traumatic: defined as the removal of the entire or a portion of (the) breast by surgery (for any reason) or as a consequence of trauma. • Congenital abnormalities: Congenital sunken chest is defined as a congenital deformity of the chest wall and the anterior ribs, resulting from a number of abnormalities of the sternum and the anterior ribs; Congenital protruding chest is defined as a congenital deformity of the chest wall and the anterior ribs, resulting from a number of abnormalities of the sternum and the anterior ribs; and Severe asymmetry is defined as a significant difference in the size of the chest wall, either congenital or acquired, as a result of a significant body deformity (e.g., Poland syndrome). • Severe ptosis of the breast, defined as requiring a specialized reconstructive procedure (e.g., breast lift). • Patients requiring a breast surgery procedure to correct a severely deformed breast, regardless of the initial indication for implantation or the type of implantation device. • Patients requiring a breast augmentation procedure on the non-operated side, as a consequence of one of the above indications, on the operated side (e.g., mastectomy of one breast and augmentation of the other breast to achieve symmetry). • Reconstructive or corrective surgery for patients who have undergone breast augmentation or breast reconstruction with a gel-filled silicone or saline-filled implant.
- Registration Date
- Apr 18, 2023
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