federal_register: 2016-03331

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2016-03331 Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems Rule 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. 2016-02-18 2016 2 https://www.federalregister.gov/documents/2016/02/18/2016-03331/effective-date-of-requirement-for-premarket-approval-for-total-metal-on-metal-semi-constrained-hip https://www.govinfo.gov/content/pkg/FR-2016-02-18/pdf/2016-03331.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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