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 | 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 |
Supplement Number | S046 |
Date Received | 09/18/2019 |
Decision Date | 12/16/2019 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for an additional configuration of the vials used for the sterile water for injection used to reconstitute the lyophilized rhBMP-2 component of Infuse Bone Graft. |
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