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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.
 
Deviceprodisc C Total Disc Replacement
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
PMA NumberP070001
Supplement NumberS018
Date Received06/21/2019
Decision Date05/08/2020
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for additional cleaning, passivation and thermal rinse steps, and the following four (4) manufacturing sites, at the following addresses, and for the following purposes:Centinel Spine (Manufacturer)900 Airport Road Suite 3BWest Chester, PA 19380Hammill Medical (Contract Manufacturer)360 Tomahawk DriveMaumee, OH 43537Fruh Verpackungstechnik AG (Contract Manufacturer)Allmendstrasse 47Fehraltoff Switzerland 8320Synergy Health Daniken AG (Contract Sterilizer)Hogenweidstrasse 6Daniken Solothurn Switzerland 4658
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