| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | PRESTIGE CERVICAL DISC SYSTEM |
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| Generic Name | Prosthesis, intervertebral disc |
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| Applicant | MEDTRONIC SOFAMOR DANEK, INC.
1800 Pyramid Place
Memphis, TN 38132 |
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| PMA Number | P060018 |
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| Date Received | 05/19/2006 |
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| Decision Date | 07/16/2007 |
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Withdrawal Date
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03/25/2021 |
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| Product Code |
MJO |
| Docket Number | 07M-0289 |
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| Notice Date | 07/20/2007 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE PRESTIGE CERVICAL DISC SYSTEM. THIS DEVICE IS INDICATED FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY. THE PRESTIGE DEVICE IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY SHOULD PRESENT WITH AT LEAST ONE OF THE FOLLOWING ITEMS PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION WHICH IS DOCUMENTED BY PATIENT HISTORY (E.G., PAIN [NECK AND/OR ARM PAIN], FUNCTIONAL DEFICIT, AND/OR NEUROLOGICAL DEFICIT), AND RADIOGRAPHIC STUDIES (E.G., CT, MRI, X-RAYS, ETC.): 1) HERNIATED DISC, AND/OR 2) OSTEOPHYTE FORMATION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 |
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