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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Deviceprodisc L Total Disc Replacement
Generic Nameprosthesis, intervertebral disc
Applicant
Centinel Spine, LLC
900 airport road, suite 3b
west chester, PA 19380
PMA NumberP050010
Supplement NumberS020
Date Received10/01/2018
Decision Date04/10/2020
Product Code MJO 
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the prodisc® L Total Disc Replacement. The prodisc® L Total Disc Replacement is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one or two adjacent vertebral level(s) from L3-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level(s). Patients receiving the prodisc® L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the prodisc® L Total Disc Replacement.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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