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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 DEVICE
Generic NameProsthesis, metatarsophalangeal joint cartilage replacement implant
ApplicantCartiva, Inc.
6120 Windward Pkwy. Suite 220
Alpharetta, GA 30005
PMA NumberP150017
Supplement NumberS002
Date Received08/01/2016
Decision Date09/29/2016
Product Code PNW 
Advisory Committee Orthopedic
Clinical TrialsNCT00969969
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the ODE Lead PMA Post-Approval Study protocol.
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