|
Device | Cartiva Synthetic Cartilage Implant |
Generic Name | Prosthesis, metatarsophalangeal joint cartilage replacement implant |
Applicant | Cartiva, Inc 6120 Windward Parkway Suite 220 Alpharetta, GA 30005 |
PMA Number | P150017 |
Supplement Number | S006 |
Date Received | 10/13/2017 |
Decision Date | 11/09/2017 |
Product Code |
PNW |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Expansion of the manufacturing facility for the Cartiva SCI device |