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 CERVICAL DISC |
Generic Name | Prosthesis, intervertebral disc |
Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P060018 |
Supplement Number | S001 |
Date Received | 09/07/2007 |
Decision Date | 09/18/2007 |
Withdrawal Date
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03/25/2021 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE SURGICAL TECHNIQUE MANUAL (I.E., MODIFICATION OF FIGURE 8 AND THE ADDITION OF A CAUTIONARY NOTE). |
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