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Device | INFUSE BONE GRAFT |
Generic Name | Bone grafting material, dental, with biologic component |
Regulation Number | 872.3930 |
Applicant | MEDTRONIC Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P050053 |
Date Received | 12/30/2005 |
Decision Date | 03/09/2007 |
Product Code |
NPZ |
Docket Number | 07M-0084 |
Notice Date | 03/13/2007 |
Advisory Committee |
Dental |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE INFUSE BONE GRAFT. THE DEVICE IS INDICATED AS AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S028 S029 S030 S031 S033 S034 S035 S036 S037 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 |