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 | OSTEONICS ABC/TRIDENT SYSTEMS |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
PMA Number | P000013 |
Supplement Number | S004 |
Date Received | 04/15/2004 |
Decision Date | 08/16/2004 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE TRIDENT "T" SHELL FOR USE WITH THE TRIDENT ALUMINA INSERT. THE TRIDENT "T" SHELL, WHICH FEATURES A THICKER SHELL WALL, IS A LINE EXTENSION TO THE TRIDENT ACETABULAR SHELLS PREVIOUSLY APPROVED FOR USE WITH THE TRIDENT ALUMINA INSERT. |
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