PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
FDA premarket approval P980052/S005 · decided 2012-10-01
Approval details
- PMA number
- P980052
- Supplement
- S005
- 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
- 2012-07-10
- Decision date
- 2012-10-01
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Freiburg
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