|
Device | PRESTIGE LP Cervical Disc |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P090029 |
Supplement Number | S014 |
Date Received | 03/18/2020 |
Decision Date | 04/15/2020 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change in the manufacturing process for machining of the Upper and Lower system components; and (2) a change to the packaging process for packaging the as sterilized Prestige LP Cervical Disc implants. |