Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
Information
Type
Rule
Regulated products
Published
February 18, 2016
Last updated
February 18, 2016
Description
Document number 2016-03331. The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)