PMA P090029S013

Device: Prestiege LP Cervical Disc - Two-Level
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P090029
Supplement: S013
Product code: MJO
Decision date: 2020-03-06
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for labeling for the Prestige LP Cervical Disc which incorporated the final results of the 10-year Extended Follow-Up of IDE Subjects Post-Approval Study.

Current openFDA PMA Record#

Device: Prestiege LP Cervical Disc - Two-Level
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P090029
Supplement: S013
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2020-03-06
Decision code: APPR
Date received: 2019-09-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for labeling for the Prestige LP Cervical Disc which incorporated the final results of the 10-year Extended Follow-Up of IDE Subjects Post-Approval Study.