PMA P150017S005
- Device
- CARTIVA SYNTHETIC CARTILAGE IMPLANT
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S005
- Product code
- PNW
- Decision date
- 2017-03-01
- Classification
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Approval order statement
- Approval for modifications to the Surgical Implantation Technique Guide for the Cartiva Synthetic Cartilage Implant to enhance safe use of the device.
Current openFDA PMA Record#
- Device
- CARTIVA SYNTHETIC CARTILAGE IMPLANT
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S005
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2017-03-01
- Decision code
- APPR
- Date received
- 2017-01-31
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the Surgical Implantation Technique Guide for the Cartiva Synthetic Cartilage Implant to enhance safe use of the device.