|
Device | CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE |
Generic Name | Prosthesis, metatarsophalangeal joint cartilage replacement implant |
Applicant | Cartiva, Inc 6120 Windward Parkway Suite 220 Alpharetta, GA 30005 |
PMA Number | P150017 |
Supplement Number | S002 |
Date Received | 08/01/2016 |
Decision Date | 09/29/2016 |
Product Code |
PNW |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00969969
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the ODE Lead PMA Post-Approval Study protocol. |