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 | S044 |
Date Received | 06/21/2016 |
Decision Date | 09/16/2016 |
Product Code |
MPW |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for increasing the size of the bioreactor used to manufacture rhBMP-2 from 6000 L to 12,000 L at the Pfizer Andover, MA Facility. |
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