|
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 | S012 |
Date Received | 02/22/2019 |
Decision Date | 03/22/2019 |
Product Code |
PNW |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding a clarifying statement regarding the need for irrigation during drilling within the Instructions for Use and the Surgical Implantation Technique for the Cartiva Synthetic Cartilage Implant. |