PMA P150017S012
- Device
- Cartiva Synthetic Cartilage Implant
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S012
- Product code
- PNW
- Decision date
- 2019-03-22
- Classification
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- 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.
Current openFDA PMA Record#
- Device
- Cartiva Synthetic Cartilage Implant
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S012
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2019-03-22
- Decision code
- APPR
- Date received
- 2019-02-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.