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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceCERAMAX® Ceramic Total Hip System
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw, IN 46582
PMA NumberP070026
Supplement NumberS086
Date Received10/13/2021
Decision Date08/10/2022
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou Jiangsu, China, as well as a sterilization site located at Shanghai JPY Ion-Tech. Co., Ltd, No. 1168, Huihin Rd., Quigpu Industrial Zone, Shanghai, China, to manufacture and sterilize SUMMIT Standard Offset Stems (Porous) Implants components of the CERAMAX® Ceramic Total Hip System.
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