Patient-Fitted TMJ Reconstruction Prosthesis System
FDA premarket approval P980052/S007 · decided 2020-01-10
Approval details
- PMA number
- P980052
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Patient-Fitted TMJ Reconstruction Prosthesis System
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Stryker Leibinger, GmbH & Co KG
- Date received
- 2019-07-11
- Decision date
- 2020-01-10
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- Approval for a manufacturing site located at TMJ Concepts, 6059 King Drive, Ventura, California.
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