|
Device | NOVUS (TM) LC INTERBODY FUSION DEVICE |
Applicant | SOFAMOR DANEK 1800 Pyramid Place 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 |
Approval Order Statement Supplement received prior to original approval. This supplement was approved as part of the original approval order. |