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Device | CERAMAX (R) 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 | S088 |
Date Received | 11/09/2021 |
Decision Date | 12/09/2021 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to remove suggested methods to re-sterilize products which have been opened (i.e., the sterile barrier breached) but not used during surgery in the Instructions for Use (IFU) for the CERAMAX® Ceramic Total Hip System. |