|
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 | S003 |
Date Received | 08/15/2016 |
Decision Date | 11/01/2016 |
Product Code |
PNW |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of 8 and 20-unit shipping configurations to accommodate smaller orders. |