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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOSTEONICS CONSTRAINED ACETABULAR INSERT
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP960047
Supplement NumberS002
Date Received03/24/2000
Decision Date05/01/2000
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - minor
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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