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FDA PMA

Prosthesis, breast, inflatable, internal, saline

PMA Number: P120011 · 2025-02-11

ApplicantBimini Health Tech
Decision Date2025-02-11
PMA NumberP120011
Product CodeFWM
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Prosthesis, breast, inflatable, internal, saline is the device name listed in this FDA 510(k) record. The listed applicant is Bimini Health Tech. It received FDA 510(k) clearance on 2025-02-11. The device is classified under product code FWM. It was reviewed by the SU advisory panel.

Frequently Asked Questions

What is the Prosthesis, breast, inflatable, internal, saline?

Prosthesis, breast, inflatable, internal, saline is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Bimini Health Tech.

When did Prosthesis, breast, inflatable, internal, saline receive FDA 510(k) clearance?

The clearance date for Prosthesis, breast, inflatable, internal, saline can be found in the official FDA records.

Who is the listed applicant for Prosthesis, breast, inflatable, internal, saline?

The FDA 510(k) record lists Bimini Health Tech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prosthesis, breast, inflatable, internal, saline?

The FDA product code for Prosthesis, breast, inflatable, internal, saline is FWM.

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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