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: PINNACLE COMPLETE ACETABULAR HIP SYSTEM
• Generic Name: Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
• Applicant: DePuy Orthopaedics, Inc.; P.O. Box 988; 700 Orthopaedic Dr.; Warsaw, IN 46581
• PMA Number: P090002
• Supplement Number: S001
• Date Received: 09/07/2011
• Decision Date: 11/04/2011
• Withdrawal Date: 09/05/2013
• Product Code: OVO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.