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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
Generic NameProsthesis, metatarsophalangeal joint cartilage replacement implant
ApplicantCartiva, Inc.
6120 Windward Pkwy. Suite 220
Alpharetta, GA 30005
PMA NumberP150017
Supplement NumberS011
Date Received01/15/2019
Decision Date07/12/2019
Product Code PNW 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the labeling to reflect the findings of the Post-Approval Study (PAS) protocol.
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