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 | NU VASIVE PCM CERVICAL DISC SYSTEM |
Generic Name | Prosthesis, intervertebral disc |
Applicant | NUVASIVE, INC. 7475 LUSK BLVD SAN DIEGO, CA 92121 |
PMA Number | P100012 |
Supplement Number | S006 |
Date Received | 09/26/2014 |
Decision Date | 12/19/2014 |
Withdrawal Date
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04/22/2020 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00578812
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LOCKING PLATE DESIGN MODIFICATION, ADDITIONAL DEVICE SIZES AND MAGNETIC RESONANCE (MR) CONDITIONAL LABELING. |
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