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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.
 
DeviceINFUSE BONE GRAFT
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
Applicant
MEDTRONIC Inc.
1800 pyramid place
memphis, TN 38132
PMA NumberP050053
Supplement NumberS013
Date Received09/01/2009
Decision Date01/14/2010
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the removal of ellman¿s assay and sds-page silver stain tests from the rhbmp-2 drug substance release specification.
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