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. |
|
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 | S015 |
Date Received | 11/06/2007 |
Decision Date | 08/15/2008 |
Product Code |
MPW
|
Advisory Committee |
Orthopedic |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO, AND A STERILIZING SITE AT STERITECH, INC., SALINAS, PUERTO RICO. |
|
|