Premarket Approval (PMA)

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(R) 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 Pl.; Memphis, TN 38132
• PMA Number: P000058
• Supplement Number: S058
• Date Received: 10/29/2014
• Decision Date: 01/27/2015
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERT AND PATIENT INFORMATIONBROCHURE (MODIFICATION OF THIS DOCUMENT WAS SUBSEQUENTLY WITHDRAWN) AS FOLLOWS:1) ADDITION OF WARNING AND PRECAUTION LANGUAGE RELATED TO DATA GENERATED FROM YOUR CERVICALSPINE STUDY; 2) CLARIFICATION TO THE POSTERIOR BONE FORMATION PRECAUTION; 3) REVISION TO THE RETROGRADE EJACULATION WARNING LANGUAGE; 4) ORGANIZATION OF THE WARNINGS INTO SIMILAR GROUPS OF ISSUES;5) REPLACEMENT OF ECTOPIC BONE FORMATION WITH HETEROTOPIC OSSIFICATION; 6) ADDITION OF SEVERAL ADDITIONAL POTENTIAL ADVERSE EVENTS; AND7) ALPHABETIZATION OF THE POTENTIAL ADVERSE EVENTS.