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FDA PMA

Prosthesis, breast, noninflatable, internal, silicone gel-filled

PMA 核准號:P230005 · 2026-09-25

決定日期2026-09-25
PMA 編號P230005
產品代碼FTR
器械分類3 類
醫療專科G
法規編號21 CFR 8
諮詢委員會SU

器材摘要

Prosthesis, breast, noninflatable, internal, silicone gel-filled is the device name listed in this FDA 510(k) record. The listed applicant is Motiva USA, LLC. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code FTR. It was reviewed by the SU advisory panel.

常見問題

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 2026-09-25. The listed applicant is Motiva USA, 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.

Who is the listed applicant for Prosthesis, breast, noninflatable, internal, silicone gel-filled?

The FDA 510(k) record lists Motiva USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prosthesis, breast, noninflatable, internal, silicone gel-filled?

The FDA product code for Prosthesis, breast, noninflatable, internal, silicone gel-filled is FTR.

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