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 | S016 |
Date Received | 11/16/2007 |
Decision Date | 03/17/2008 |
Product Code |
MPW |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR INCLUSION OF A WARNING RELATED TO LOCALIZED, TRANSIENT BONE RESORPTION IN THE PACKAGE INSERT. THE INCLUSION OF THIS ADDITIONAL WARNING WAS PROMPTED BY A LABELING MODIFICATION REQUIRED BY THE EU AS A RESULT OF AN ANALYSIS OF REPORTED ADVERSE EVENTS. |
|
|