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 | S051 |
Date Received | 10/02/2018 |
Decision Date | 11/09/2018 |
Product Code |
MPW
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Advisory Committee |
Orthopedic |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
Yes
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Approval Order Statement
Modify the General Inspection Level and Acceptable Quality Level (AQL) of the absorbable collagen sponge (ACS) component of Infuse Bone Graft to align with ISO 14971:2012. |
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