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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
59 route 17 south
allendale, NJ 07401-1677
PMA NumberP960047
Supplement NumberS002
Date Received03/24/2000
Decision Date05/01/2000
Advisory Committee Orthopedic
Supplement Typereal-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.