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 | S101 |
Date Received | 07/28/2022 |
Decision Date | 08/26/2022 |
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 |
Approval Order Statement Process change by introducing new sealing parameters and the use of six (6) cavities as opposed to the current four (4) cavitie. |
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