- Device
- Cartiva Synthetic Cartilage Implant (Cartiva SCI)
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S013
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2020-02-09
- Decision code
- APPR
- Date received
- 2019-08-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Steris (Synergy Health AST, LLC), 7225 North Noah Drive, Saxonburg, Pennsylvania, 16056-9704 for device sterilization.