|
Device | Cartiva SCI reusable instrumentation |
Generic Name | Prosthesis, metatarsophalangeal joint cartilage replacement implant |
Applicant | Cartiva, Inc 6120 Windward Parkway Suite 220 Alpharetta, GA 30005 |
PMA Number | P150017 |
Supplement Number | S007 |
Date Received | 11/15/2017 |
Decision Date | 08/28/2018 |
Product Code |
PNW |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Arcamed LLC, 5101 Decatur Blvd Ste A, Indianapolis, Indiana to manufacture the instruments for Cartiva Synthetic Cartilage Implant. |