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/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 | S001 |
Date Received | 07/23/2002 |
Decision Date | 10/04/2002 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL CLINICAL STUDY FOR THE DEVICE. THE POST-APPROVAL CLINICAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE JULY 2, 2002 APPROVAL ORDER FOR P000058. |
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