PMA P070026S063
- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S063
- Product code
- MRA
- Decision date
- 2019-07-19
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Approval for several changes to the approved post-approval study (PAS) protocol for the 36mm (COC36) newly enrolled subjects including, allowing any AP and Lateral radiographs that provide the required data points, expanding the time window for pre-op radiographs, and allowing telephone follow-up for 3- and 4-year visits.
Current openFDA PMA Record#
- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S063
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2019-07-19
- Decision code
- APPR
- Date received
- 2019-05-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for several changes to the approved post-approval study (PAS) protocol for the 36mm (COC36) newly enrolled subjects including, allowing any AP and Lateral radiographs that provide the required data points, expanding the time window for pre-op radiographs, and allowing telephone follow-up for 3- and 4-year visits.