PMA P150017S001
- Device
- CARTIVA SYNTHETIC CARTILAGE IMPLANT
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S001
- Product code
- PNW
- Decision date
- 2016-08-25
- Classification
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Approval order statement
- Change the vendor that supplies the foil lidstock used to seal the primary packaging of the Cartiva SCI device.
Current openFDA PMA Record#
- Device
- CARTIVA SYNTHETIC CARTILAGE IMPLANT
- Applicant
- Cartiva, Inc.
- PMA number
- P150017
- Supplement
- S001
- Product code
- PNW
- Generic name
- Prosthesis, metatarsophalangeal joint cartilage replacement implant
- Decision date
- 2016-08-25
- Decision code
- OK30
- Date received
- 2016-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the vendor that supplies the foil lidstock used to seal the primary packaging of the Cartiva SCI device.