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. |
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Device | CERAMAX® Ceramic Total Hip System |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46582 |
PMA Number | P070026 |
Supplement Number | S086 |
Date Received | 10/13/2021 |
Decision Date | 08/10/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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