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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 CERVICAL DISC
Generic NameProsthesis, intervertebral disc
ApplicantMedtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP060018
Supplement NumberS002
Date Received10/26/2010
Decision Date03/24/2011
Withdrawal Date03/25/2021
Product Code MJO 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-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 FOR A CHANGE OF LOCATION OF THE ORCHID ANZON (FORMERLY ANZON COMPANY, INC.) FACILITY.
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