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 CONSTRAINED ACETABULAR INSERT |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH ALLENDALE, NJ 07401-1677 |
PMA Number | P960047 |
Supplement Number | S002 |
Date Received | 03/24/2000 |
Decision Date | 05/01/2000 |
Reclassified Date
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04/30/2002 |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of the Trident Constrained Acetabular insert design, and the Modified PCA Co Cr, Modified V40 Co Cr, PCA CoCr+15 mm, PCA Zirconia and V40 Zirconia Femoral Heads to the Osteonics Constrained Acetabular Insert PMA. |
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