Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: RCHS Ceramic Liners and Shells
• Generic Name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
• Applicant: Smith & Nephew, Inc.; 1450 Brooks Rd.; Memphis, TN 38116
• PMA Number: P030022
• Supplement Number: S044
• Date Received: 07/19/2017
• Decision Date: 08/17/2017
• Withdrawal Date: 08/31/2022
• Product Code: MRA
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change in the outer packaging carton for P030022, so that it is consistent with the approved packaging.