Prosthesis, spinous process spacer/plate

Prosthesis, spinous process spacer/plate is the device name listed in this FDA PMA record. The listed applicant is Boston Scientific Neuromodulation. It received FDA Premarket Approval (PMA) on 2024-11-07 under PMA number P140004. The device is classified under FDA product code NQO. It was reviewed by the OR 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 U. Product code NQO belongs to the General Hospital category, which covers general-purpose hospital equipment and supplies. 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.