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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.
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
PMA NumberP050053
Supplement NumberS010
Date Received12/02/2008
Decision Date01/20/2010
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an additional supplier of bovine achilles tendon for the manufacture of the absorbable collagen sponge (acs) component of the infuse bone graft.