TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
FDA premarket approval P980052/S002 · decided 2003-01-14
Approval details
- PMA number
- P980052
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Stryker Leibinger, GmbH & Co KG
- Date received
- 2002-11-27
- Decision date
- 2003-01-14
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- APPROVAL FOR THE ADDITION OF THE STERILE PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TO BE STERILIZED AT TMJ CONCEPTS, VENTURA, CALIFORNIA.
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