|
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 | S022 |
Date Received | 10/24/2018 |
Decision Date | 04/26/2019 |
Product Code |
NQA |
Advisory Committee |
Dental |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to change the test lab for water testing from APL to Mikrolab Stockholm AB |