|
Device | 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 | S009 |
Date Received | 04/11/2006 |
Decision Date | 04/24/2006 |
Product Code |
NQA |
Advisory Committee |
Dental |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF POST-MARKET EXPERIENCE INFORMATION TO THE WARNING SECTION OF THE EMDOGAIN PACKAGE INSERT. |