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. |
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Device | PRESTIGE: LP(TM) CERVICAL DISC |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P090029 |
Supplement Number | S008 |
Date Received | 07/13/2017 |
Decision Date | 01/31/2018 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for manufacturing sites located at MedTorque, Inc., 612 W. Lamont Road, Elmhurst, Illinois, for instrument machining and laser marking of the BRYAN™ and PRESTIGE LP instruments, and at Medtronic Sofamor Danek USA, Inc., 4340 Swinnea Road, Memphis, Tennessee, for the manufacturing of PRESTIGE LP Streamlined Instrument. |
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