PMA P150017S009
- Device
- Cartiva SCI
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S009
- Product code
- PNW
- Decision date
- 2018-07-02
- Classification
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Approval order statement
- Add an additional clean room for use in the manufacture of Cartiva SCI Implant.
Current openFDA PMA Record#
- Device
- Cartiva SCI
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S009
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2018-07-02
- Decision code
- OK30
- Date received
- 2018-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional clean room for use in the manufacture of Cartiva SCI Implant.