PMA P150017S002
- Device
- CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S002
- Product code
- PNW
- Decision date
- 2016-09-29
- Classification
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Approval order statement
- Approval of the protocol for the ODE Lead PMA Post-Approval Study protocol.
Current openFDA PMA Record#
- Device
- CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S002
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2016-09-29
- Decision code
- APPR
- Date received
- 2016-08-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the ODE Lead PMA Post-Approval Study protocol.