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PMA P060018S004

Device
PRESTIGE® Cervical Disc
Applicant
Medtronic Sofamor Danek, Inc.
PMA number
P060018
Supplement
S004
Product code
MJO
Decision date
2016-07-20
Generic name
Prosthesis, intervertebral disc
Approval order statement
Approval for 1) A 7-year post-approval study to evaluate the longer term safety and effectiveness of the PRESTIGE Cervical Disc. The study will involve the investigational and control patients from the pivotal investigational device exemption (IDE) study arm, as well as the patients who received the device as part of the continued access study (CAS) arm. Data will be collected at 3 years (36 months), 5 years (60 months), and 7 years (84 months) postoperatively for all patients. At each time point, Medtronic will collect the following data: Neck Disability Index score; radiographic information; and neurological status. In addition, all adverse events, including details of the nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome reported for these patients will also be collected. Reports will be submitted annually until the completion of the study. The results of this long-term data must be reflected in the labeling (via supplement) when the post-approval study is completed, as well as any other time point deemed necessary by FDA if significant new information from this study becomes available.2) A 5-year enhanced surveillance study of the PRESTIGE Cervical Disc to fully characterize adverse events when the device is used in a broader patient population. Medtronic will collect, analyze, and submit all adverse events and complaints received by the company for the PRESTIGE Cervical Disc, as well as information on the total number of devices shipped. The study will commence at the time of PMA approval and reports will be submitted every six months for the first two years and then annually through the fifth year.

Current openFDA PMA Record#

Device
PRESTIGE® Cervical Disc
Applicant
Medtronic Sofamor Danek, Inc.
PMA number
P060018
Supplement
S004
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2016-07-20
Decision code
APPR
Date received
2016-01-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - PAS
Approval order statement
Approval for 1) A 7-year post-approval study to evaluate the longer term safety and effectiveness of the PRESTIGE Cervical Disc. The study will involve the investigational and control patients from the pivotal investigational device exemption (IDE) study arm, as well as the patients who received the device as part of the continued access study (CAS) arm. Data will be collected at 3 years (36 months), 5 years (60 months), and 7 years (84 months) postoperatively for all patients. At each time point, Medtronic will collect the following data: Neck Disability Index score; radiographic information; and neurological status. In addition, all adverse events, including details of the nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome reported for these patients will also be collected. Reports will be submitted annually until the completion of the study. The results of this long-term data must be reflected in the labeling (via supplement) when the post-approval study is completed, as well as any other time point deemed necessary by FDA if significant new information from this study becomes available.2) A 5-year enhanced surveillance study of the PRESTIGE Cervical Disc to fully characterize adverse events when the device is used in a broader patient population. Medtronic will collect, analyze, and submit all adverse events and complaints received by the company for the PRESTIGE Cervical Disc, as well as information on the total number of devices shipped. The study will commence at the time of PMA approval and reports will be submitted every six months for the first two years and then annually through the fifth year.