Prosthesis, breast, inflatable, internal, saline

Prosthesis, breast, inflatable, internal, saline is the device name listed in this FDA PMA record. The listed applicant is Bimini Health Tech. It received FDA Premarket Approval (PMA) on 2025-02-11 under PMA number P120011. 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 valid scientific evidence providing reasonable assurance of safety and effectiveness. 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.