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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 NameAUGMEN(TM) AKA SYNTHOGRAFT(TM) LG
Classification Nameimplant, endosseous, root-form
Generic Namecalcium phosphate-ceramic
Regulation Number872.3640
ApplicantBOEHRINGER MANNHEIM CORP.
PMA NumberP800035
Supplement NumberS008
Date Received10/11/1983
Decision Date11/10/1983
Product Code
DZE[ Registered Establishments with DZE ]
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
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