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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 (Cartiva SCI)
Generic NameProsthesis, metatarsophalangeal joint cartilage replacement implant
ApplicantCartiva, Inc
6120 Windward Parkway
Suite 220
Alpharetta, GA 30005
PMA NumberP150017
Supplement NumberS010
Date Received10/05/2018
Decision Date07/11/2019
Product Code PNW 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of 6 mm and 12 mm sizes of the Cartiva SCI device to the previously approved 8 mm and 10 mm sizes of the device.
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