|
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 | S010 |
Date Received | 05/20/2004 |
Decision Date | 06/10/2004 |
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 1) AN INCREASE IN THE EXPIRATION DATE OF THE 4.2 AND 12 MG VIALED RHBMP-2 COMPONENT OF THE REFERENCED DEVICES FROM 36 TO 48 MONTHS; 2) AN INCREASE IN THE EXPIRATION DATE OF THE COMMERCIAL KIT COMPONENT FROM 24 TO 36 MONTHS; AND 3) THE PROTOCOL TO BE FOLLOWED FOR ALL FUTURE EXPIRATION DATE CHANGES. |