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 | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
Applicant |
Medtronic Sofamor Danek USA, Inc. |
1800 pyramid place |
memphis, TN 38132 |
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PMA Number | P000054 |
Supplement Number | S039 |
Date Received | 03/07/2013 |
Decision Date | 05/31/2013 |
Product Code |
MPW
|
Advisory Committee |
Orthopedic |
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 MODIFICATIONS TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF STUDY 400. |
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