- Device
- Trident Ceramic System
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S017
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2020-09-30
- Decision code
- APPR
- Date received
- 2020-07-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change of the de-nesting lubricant sprayed on polyethylene terephthalate glycol sheets that are thermoformed into blister trays used in Trident Alumina Inserts packaging.