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 | S005 |
Date Received | 09/09/2004 |
Decision Date | 10/22/2004 |
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 FOR EXPANDED INDICATIONS FOR USE (INFLAMMATORY JOINT DISEASE AND REVISION HIP ARTHROPLASTY) AS WELL AS REVISIONS TO THE PACKAGE INSERT AND PATIENTS LABELING. |
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