PMA P010001S005
- Device
- CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S005
- Product code
- MRA
- Decision date
- 2010-07-06
- 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 THE ADDITION OF A SECOND MANUFACTURING LINE AT THE MARKTREDWITZ, GERMANY FACILITY.
Current openFDA PMA Record#
- Device
- CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S005
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2010-07-06
- Decision code
- APPR
- Date received
- 2010-03-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SECOND MANUFACTURING LINE AT THE MARKTREDWITZ, GERMANY FACILITY.