PMA P980052S008
- Device
- Patient-Fitted TMJ Reconstruction Prosthesis System
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S008
- Product code
- LZD
- Decision date
- 2020-11-24
- Generic name
- Joint, temporomandibular, implant
- Approval order statement
- Change to implement new sterilization equipment for the same approved sterilization type and cycle.
Current openFDA PMA Record#
- Device
- Patient-Fitted TMJ Reconstruction Prosthesis System
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S008
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2020-11-24
- Decision code
- OK30
- Date received
- 2020-10-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to implement new sterilization equipment for the same approved sterilization type and cycle.