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 | DURALOC OPTION CERAMIC HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P040023 |
Supplement Number | S012 |
Date Received | 11/18/2008 |
Decision Date | 12/30/2008 |
Withdrawal Date
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04/03/2014 |
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 CERAMTEC AG, MARKTREDWITZ, GERMANY, FOR MANUFACTURING OF THE BIOLOX FORTE CERAMIC HEADS AND LINERS. |
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