PMA P030027S001
- Device
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S001
- Product code
- MRA
- Decision date
- 2006-02-16
- 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
- MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC., FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS
Current openFDA PMA Record#
- Device
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S001
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2006-02-16
- Decision code
- OK30
- Date received
- 2006-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC., FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS