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FDA PMA

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

PMA Number: P030053 · 2026-07-21

ApplicantMentor Corp.
Decision Date2026-07-21
PMA NumberP030053
Product CodeFTR
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Prosthesis, breast, noninflatable, internal, silicone gel-filled is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. 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.

Frequently Asked Questions

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 Corp..

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 Mentor Corp. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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