- Device
- Cartiva Synthetic Cartilage Implant
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S011
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2019-07-12
- Decision code
- APPR
- Date received
- 2019-01-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the labeling to reflect the findings of the Post-Approval Study (PAS) protocol.