PMA P070026S043
- Device
- CERAMAX CERAMIC HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S043
- Product code
- MRA
- Decision date
- 2016-11-28
- 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 the addition of a verification step for the manufacturing operator to visually and audibly confirm once per shift that the ultrasonic generators turn on and transducers are audibly energized.
Current openFDA PMA Record#
- Device
- CERAMAX CERAMIC HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S043
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2016-11-28
- Decision code
- APPR
- Date received
- 2016-10-31
- Supplement type
- Special
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a verification step for the manufacturing operator to visually and audibly confirm once per shift that the ultrasonic generators turn on and transducers are audibly energized.