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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.
 
DeviceEMDOGAIN GEL
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantTHE STRAUMANN COMPANY
60 Minuteman Road
Andover, MA 01810
PMA NumberP930021
Supplement NumberS007
Date Received07/01/2002
Decision Date05/20/2003
Product Code NQA 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE ADDITIONAL INDICATIONS FOR USE AS AN ADJUNCT TO PERIODONTAL SURGERY FOR MANDIBULAR CLASS II FURCATIONS WITH MINIMAL INTERPROXIMAL BONE LOSS.
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