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. |
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Device | Straumann Emdogain |
Generic Name | Biologic material, dental |
Regulation Number | 872.3930 |
Applicant | THE STRAUMANN COMPANY 60 Minuteman Road Andover, MA 01810 |
PMA Number | P930021 |
Supplement Number | S030 |
Date Received | 01/04/2023 |
Decision Date | 02/03/2023 |
Product Code |
NQA |
Advisory Committee |
Dental |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a second supplier, Eurofins BioPharma Product Testing Sweden AB, for sterility testing (release testing). |
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