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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
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantTHE STRAUMANN COMPANY
60 Minuteman Road
Andover, MA 01810
PMA NumberP930021
Supplement NumberS003
Date Received05/20/1999
Decision Date08/24/1999
Product Code NQA 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for packaging changes for EMDOGAIN(R). The following packaging changes are now approved: 1) a change in the size of the glass vial in which the EMDOGAIN powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10 mg of the product in addition to the originally approved 30 mg of the product.
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