|
Device | INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE |
Generic Name | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P000058 |
Supplement Number | S041 |
Date Received | 09/30/2010 |
Decision Date | 08/03/2012 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGES TO TESTS PERFORMED AS PART OF THE ONGOING DRUG PRODUCT STABILITY PROGRAM FOR RHBMP-2 (DIBOTERMIN ALFA). |