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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 Rd.
Andover, MA 01810
PMA NumberP930021
Supplement NumberS011
Date Received03/27/2008
Decision Date06/19/2009
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 ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING: 1) THE USE OF STRAUMANN EMDOGAIN WITH BONE SUBSTITUTE MATERIAL, SUCH AS STRAUMANN BONE CERAMIC; 2) LABELING CHANGES TO MODIFY A STATEMENT REGARDING THE LONG TERM STABILITY OF REGENERATED TISSUE; 3) LABELING CHANGE TO ADD ADDITIONAL SURGICAL TECHNIQUES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS; 4) LABELING CHANGE TO INCLUDE INSTRUCTIONS IN THE ¿STORAGE¿ SECTION IN INSTRUCTIONS FOR USE FOR HOMOGENIZATION IF THE MATERIAL IS SEPARATED IN THE SYRINGE; AND 5) CLARIFY THE INSTRUCTIONS UNDER EACH OF THE THREE CLINICAL PROCEDURES IN THE INSTRUCTIONS FOR USE TO BETTER ALIGN THEM WITH ONE ANOTHER.
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