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 | S054 |
Date Received | 10/25/2013 |
Decision Date | 12/06/2013 |
Product Code |
NEK |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR EXTENSION OF THE RHBMP-2 DRUG SUBSTANCE EXPIRATION DATE FROM 60 TO 72 MONTHS USING THE APPROVED EXPIRATION DATE MODIFICATION PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICES AND IS INDICATED FOR THE FOLLOWING: SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, FUNCTION DEFICIT AND/OR NEUROLOGICAL DEFICIT AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. INFUSE® BONE GRAFT/LT-CAGE DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR A LAPAROSCOPIC APPROACH. PATIENTS RECEIVING THE INFUSE® BONE GRAFT/ LT-CAGE® LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE® BONE GRAFT/LT-CAGE® DEVICE. |
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