PMA P150017S003
- Device
- CARTIVA SYNTHETIC CARTILAGE IMPLANT
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S003
- Product code
- PNW
- Decision date
- 2016-11-01
- Classification
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Approval order statement
- Approval for the addition of 8 and 20-unit shipping configurations to accommodate smaller orders.
Current openFDA PMA Record#
- Device
- CARTIVA SYNTHETIC CARTILAGE IMPLANT
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S003
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2016-11-01
- Decision code
- APPR
- Date received
- 2016-08-15
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of 8 and 20-unit shipping configurations to accommodate smaller orders.