Patient-Fitted TMJ Reconstruction Prosthesis System
FDA premarket approval P980052/S008 · decided 2020-11-24
Approval details
- PMA number
- P980052
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2020-10-27
- Decision date
- 2020-11-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
- Statement
- Change to implement new sterilization equipment for the same approved sterilization type and cycle.
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