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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCARTIVA SYNTHETIC CARTILAGE IMPLANT
Classification Nameprosthesis, metatarsophalangeal joint cartilage replacement implant
Generic Nameprosthesis, metatarsophalangeal joint cartilage replacement implant
Applicant
Cartiva, Inc
6120 windward parkway
suite 220
alpharetta, GA 30005
PMA NumberP150017
Date Received05/01/2015
Decision Date07/01/2016
Product Code
PNW[ Registered Establishments with PNW ]
Docket Number 16M-1916
Notice Date 07/08/2016
Advisory Committee Orthopedic
Clinical Trials NCT00969969
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use in the treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 
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