|
Device | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE |
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 | S021 |
Date Received | 03/16/2009 |
Decision Date | 05/13/2009 |
Product Code |
MPW
|
Advisory Committee |
Orthopedic |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
APPROVAL FOR A MODIFICATION TO THE PACKAGE INSERTS. SPECIFICALLY, ADDING TEXT TO ONE OF THE WARNINGS TO ADDRESS AES AND POTENTIAL SURGICAL INTERVENTIONS ASSOCIATED WITH IMPROPER USE OF THE RHBMP-2/ACS COMPONENTS OF THE PRODUCTS. |