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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.
 
DeviceSTRAUMANN EMDOGAIN(R)
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantThe Straumann Company
60 Minuteman Rd.
Andover, MA 01810
PMA NumberP930021
Supplement NumberS016
Date Received04/06/2016
Decision Date03/28/2017
Product Code NQA 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) adding an alternate glass syringe supplier (Design Change); 2) adding an alternate tamper-evident luer cap design (Design Change); 3) adding an alternate cavity design of the thermoformed tray; part of the secondary sterile barrier packaging (Design Change); 4) adding an alternate supplier of the Tyvek 1073B lid stock which includes a change in adhesive coating; part of the secondary sterile barrier packaging (Design Change); in addition, addressing the change to Transition Tyvek with this supplement; and 4) changing the configuration, artwork and labeling of the tertiary shelf packaging (Design Change).
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