假体，乳房，不可充气，内部，硅胶填充
PMA编号：P060028 · 2026-07-21
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决定日期2026-07-21
PMA 编号P060028
产品代码FTR
设备分类第3类
医疗专科G
法规编号21 CFR 8
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
器械摘要
Prosthesis, breast, noninflatable, internal, silicone gel-filled is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code FTR. It was reviewed by the SU advisory panel.
常见问题
What is the Prosthesis, breast, noninflatable, internal, silicone gel-filled?
Prosthesis, breast, noninflatable, internal, silicone gel-filled is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Mentor Worldwide, LLC.
When did Prosthesis, breast, noninflatable, internal, silicone gel-filled receive FDA 510(k) clearance?
The clearance date for Prosthesis, breast, noninflatable, internal, silicone gel-filled can be found in the official FDA records.
谁是被列为假体、乳房、非充气、内部、硅胶填充物的申请人？
The FDA 510(k) record lists Mentor Worldwide, LLC as the applicant. This does not by itself establish the device manufacturer.
什么是FDA假体产品代码，用于非充气、内部、硅胶凝胶填充的乳房假体？
FDA产品代码为Prosthesis, breast, noninflatable, internal, silicone gel-filled的假体是FTR。
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官方来源
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