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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 NumberS001
Date Received08/01/2016
Decision Date08/25/2016
Product Code PNW 
Advisory Committee Orthopedic
Clinical TrialsNCT00969969
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Change the vendor that supplies the foil lidstock used to seal the primary packaging of the Cartiva SCI device.
Post-Approval StudyShow Report Schedule and Study Progress
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