- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S072
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2020-06-26
- Decision code
- APPR
- Date received
- 2020-05-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Extension of the final 5-6 years window by 365 days to allow time to collect the primary endpoint as a result of the COVID-19 pandemic.