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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.
 
DevicePrestige LP (R) Cervical Disc
Generic NameProsthesis, intervertebral disc
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP090029
Supplement NumberS020
Date Received04/02/2024
Decision Date05/01/2024
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change of the film adhesive used in tensile testing of the titanium plasma spray coating and a change in material for the masking/fixturing in the titanium sprayed coating process of the PRESTIGE LP® Cervical Disc
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