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. |
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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 | S033 |
Date Received | 10/20/2011 |
Decision Date | 07/17/2012 |
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 MODIFICATIONS TO THE LABELING FOR THE IDENTIFIED PRODUCTS.SPECIFICALLY YOU REQUESTED THE FOLLOWING: 1) AN ADDITIONAL WARNING TO ADDRESS CONCERNS RELATED TO THE USE OF POTENTIAL PATIENTS WITH A SUSPECTED MALIGNANCY; 2) AN ADDITIONAL WARNING RELATED TO DEVICE MIGRATION; 3) A MODIFICATION TO THE PRECAUTION RELATED TO ECTOPIC, HETEROTOPIC AND EXUBERANT BONE FORMATION BY REMOVING THE INITIAL QUALIFYING LANGUAGE: AND 4) A MODIFICATION TO THE DESCRIPTION OF THE RECONSTITUTED RECOMBINANT PROTEIN SOLUTION, I.E., "...COLORLESS TO SLIGHTLY YELLOW..." |
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