Prodisc®-L FDA Docs: Approval 8/14/06, Summary of Safety Effectiveness Data, Labeling

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FDA (Food and Drug Administration)
Center for Devices and Radiological Health

PRODISC®-L Total Disc Replacement- P050010
Issued August 14, 2006 <UL TYPE=SQUARE>Prodisc®-L - Approval Order: Link
Prodisc-L - Summary of Safety and Effectiveness DataLink
Prodisc-L - Professional Labeling Link
Prodisc-L - Patient Labeling Link
Prodisc-L - Other Consumer Information: Link[/list]~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Prodisc-L was in a clinical trial comparing the results to Circumferential Fusion (anterior-posterior).

Summary of Safety and Effectiveness Data includes:<UL TYPE=SQUARE>Table 3 Time Course of All Adverse Events, pg 3
Table 4: Device-related Adverse Events, pg 5
Table 10: Expulsion Test Results, pg 11[/list]Professional Labeling includes:<UL TYPE=SQUARE>Table 3: Time Course of All Adverse Events
Inclusion - Exclusion Criteria
Success Criteria: Sponsor, FDA
Patient Demographics
Time Course of Mean Flexion / Extension ROM[/list]
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