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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 SCI
Generic NameProsthesis, metatarsophalangeal joint cartilage replacement implant
ApplicantCartiva, Inc
6120 Windward Parkway
Suite 220
Alpharetta, GA 30005
PMA NumberP150017
Supplement NumberS009
Date Received06/06/2018
Decision Date07/02/2018
Product Code PNW 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add an additional clean room for use in the manufacture of Cartiva SCI Implant.
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