PMA P030027S008
- Device
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S008
- Product code
- MRA
- Decision date
- 2015-12-30
- 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
- ADDITION OF CERAMTECH'S MARKTREDWITZ FACILITY FOR THE USE OF THE HOT ISOSTATIC PRESSURE (HIP) PROCESS.
Current openFDA PMA Record#
- Device
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S008
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2015-12-30
- Decision code
- OK30
- Date received
- 2015-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF CERAMTECH'S MARKTREDWITZ FACILITY FOR THE USE OF THE HOT ISOSTATIC PRESSURE (HIP) PROCESS.