Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
• Classification Name: prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
• Applicant: DEPUY, INC.
• PMA Number: P070026
• Supplement Number: S011
• Date Received: 10/31/2012
• Decision Date: 02/19/2013
• Product Code: MRA [ Registered Establishments with MRA ]
• Advisory Committee: Orthopedic
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the post-approval protocol.