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 | NuVasive PCM Cervical Disc |
Generic Name | Prosthesis, intervertebral disc |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD SAN DIEGO, CA 92121 |
PMA Number | P100012 |
Supplement Number | S008 |
Date Received | 05/03/2018 |
Decision Date | 04/03/2019 |
Withdrawal Date
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04/22/2020 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT01905930
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Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling updated to include post-approval study results. |
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