TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
FDA premarket approval P980052/S015 · decided 2024-08-08
Approval details
- PMA number
- P980052
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Stryker Leibinger, GmbH & Co KG
- Date received
- 2024-08-01
- Decision date
- 2024-08-08
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- change of the current Process Challenge Device (PCD) used during the in-house 100% ethylene oxide (EO) sterilization of the Patient-Fitted TMJ Implants at the TMJ Concepts facility located in Ventura, CA
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