PMA P010001S009
- Device
- CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S009
- Product code
- MRA
- Decision date
- 2012-04-19
- 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 USE OF ADDITIONAL AND REPLACEMENT MACHINES FOR GRINDING, POLISHING AND DIMENSIONAL INSPECTION.
Current openFDA PMA Record#
- Device
- CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S009
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2012-04-19
- Decision code
- APPR
- Date received
- 2011-03-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR USE OF ADDITIONAL AND REPLACEMENT MACHINES FOR GRINDING, POLISHING AND DIMENSIONAL INSPECTION.