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: NOVUS (TM) LC INTERBODY FUSION DEVICE
• Applicant: Sofamor Danek; 1800 Pyramid Pl.; Memphis, TN 38132
• PMA Number: P970015
• Supplement Number: S001
• Date Received: 06/15/1998
• Decision Date: 05/14/1999
• Reclassified Date: 07/12/2007
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Supplement received prior to original approval. This supplement was approved as part of the original approval order.