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 | PRESTIGE LP CERVICAL DISC SYSTEM |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P090029 |
Supplement Number | S005 |
Date Received | 07/11/2016 |
Decision Date | 08/11/2016 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Site change for a manufacturing supplier. |
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