- Device
- CERAMIC TRANSCEND HIP ARTICULATION
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S009
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2016-09-01
- Decision code
- APPR
- Date received
- 2016-03-11
- 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 Sterigenics US LLC, 1700 College Blvd, West Memphis, Arizona, 72301.