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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 NumberS005
Date Received01/31/2017
Decision Date03/01/2017
Product Code PNW 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
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 modifications to the Surgical Implantation Technique Guide for the Cartiva Synthetic Cartilage Implant to enhance safe use of the device.
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