implant
(5) Implant The term “implant” means— (A) a medical device that is intended by the manufacturer of the device— (i) to be placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days; or (ii) to remain in contact with bodily fluids or internal human tissue through a surgically produced opening for a period of less than 30 days; and (B) suture materials used in implant procedures.