PMA P980052S011
- Device
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S011
- Product code
- LZD
- Decision date
- 2022-08-31
- Generic name
- Joint, temporomandibular, implant
- Approval order statement
- Addition of a back-up Ethylene Oxide Sterilizer.
Current openFDA PMA Record#
- Device
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S011
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2022-08-31
- Decision code
- OK30
- Date received
- 2022-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a back-up Ethylene Oxide Sterilizer.