PMA P070026S065
- Device
- CERAMAX CERAMIC HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S065
- Product code
- MRA
- Decision date
- 2019-08-06
- 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 a manufacturing site located at DePuy (Ireland) , Loughbeg, Ringaskiddy Co. CORK, Ireland, for coating, machining, cleaning, and packaging of the Summit femoral stems.
Current openFDA PMA Record#
- Device
- CERAMAX CERAMIC HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S065
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2019-08-06
- Decision code
- APPR
- Date received
- 2019-07-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at DePuy (Ireland) , Loughbeg, Ringaskiddy Co. CORK, Ireland, for coating, machining, cleaning, and packaging of the Summit femoral stems.