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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 Cervical Disc
Generic NameProsthesis, intervertebral disc
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP090029
Supplement NumberS015
Date Received10/21/2020
Decision Date12/01/2020
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  
Approval to replace the current deionized water system to a new reverse osmosis & deionized water system with new piping and fixtures. This change applies to the water system is being replaced by a new reverse osmosis & deionized water system with new piping and fixtures. The following manufacturing facility is affected by the change(s): Orchid Orthopedics Solutions, 23149 Commerce Drive, Farmington Hills, MI 48335 USA.
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