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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.
 
DeviceCartiva Synthetic Cartilage Implant (SCI)
Generic NameProsthesis, metatarsophalangeal joint cartilage replacement implant
ApplicantCartiva, Inc.
6120 Windward Pkwy. Suite 220
Alpharetta, GA 30005
PMA NumberP150017
Supplement NumberS015
Date Received06/30/2021
Decision Date12/10/2021
Product Code PNW 
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Building C, 11576 Memphis-Arlington Road, Arlington, Tennessee 38002 as a secondary manufacturing and packaging site of Cartiva SCI devices.
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