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 |
PMA Number | P000054 |
Supplement Number | S070 |
Date Received | 07/27/2023 |
Decision Date | 08/21/2023 |
Product Code |
MPW |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Manufacturing changes including modifications to two ISO 7 Collagen Packaging Cleanrooms and the associated Gowning Room and the replacement of the Honeywell temperature recorders with the Viewpoint Temperature Monitoring system at the Collagen Manufacturing Center (CMC) located at 105 Morgan Lane, Plainsboro, NJ 08536 |
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