Page "Biomedical engineering" Paragraph 55

# Class III devices generally require premarket approval ( PMA ) or premarket notification ( 510k ), a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I.

Examples include replacement heart valves, hip and knee joint implants, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous ( intra-bone ) implants.