PMA P980052S004
- Device
- PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S004
- Product code
- LZD
- Decision date
- 2009-09-02
- Classification
- Joint, Temporomandibular, Implant
- Generic name
- Joint, temporomandibular, implant
- Approval order statement
- APPROVAL FOR MODIFIED LABELING.
Current openFDA PMA Record#
- Device
- PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
- Applicant
- Stryker Leibinger, GmbH & Co KG
- PMA number
- P980052
- Supplement
- S004
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2009-09-02
- Decision code
- APPR
- Date received
- 2009-03-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFIED LABELING.