|
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 | S028 |
Date Received | 01/14/2008 |
Decision Date | 12/04/2008 |
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 A CHANGE IN THE SPECIFIC ACTIVITY SPECIFICATION RANGE OF DIBOTERMIN ALFA DRUG SUBSTANCE AND DRUG PRODUCT. |