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FDA PMA

Prosthesis, breast, inflatable, internal, saline

PMA Number: P990075 · 2026-05-12

ApplicantMentor Worldwide, LLC
Decision Date2026-05-12
PMA NumberP990075
Product CodeFWM
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Prosthesis, breast, inflatable, internal, saline is a medical device manufactured by Mentor Worldwide, LLC. It received FDA Premarket Approval (PMA) on 2026-05-12 under PMA number P990075. The device is classified under FDA product code FWM. It was reviewed by the SU advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of G. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

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

Prosthesis, breast, inflatable, internal, saline is a medical device that received FDA Premarket Approval (PMA) on 2026-05-12. It is manufactured by Mentor Worldwide, LLC. The PMA number is P990075.

When did Prosthesis, breast, inflatable, internal, saline receive FDA PMA approval?

Prosthesis, breast, inflatable, internal, saline received FDA PMA approval on 2026-05-12, under approval number P990075.

What company makes Prosthesis, breast, inflatable, internal, saline?

Prosthesis, breast, inflatable, internal, saline is manufactured by Mentor Worldwide, LLC.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

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

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

What FDA device class is Prosthesis, breast, inflatable, internal, saline?

Prosthesis, breast, inflatable, internal, saline is classified as Class III by the FDA.

Official Source

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

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