Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 Parkway
Suite 220
Alpharetta, GA 30005
PMA NumberP150017
Supplement NumberS001
Date Received08/01/2016
Decision Date08/25/2016
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  
Change the vendor that supplies the foil lidstock used to seal the primary packaging of the Cartiva SCI device.
-
-