PMA P010001S001
- Device
- CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S001
- Product code
- MRA
- Decision date
- 2003-04-04
- 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 THE LINEAGE ACETABULAR SHELL TO BE USED WITH THE TRANSCEND CERAMIC LINERS.
Current openFDA PMA Record#
- Device
- CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S001
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2003-04-04
- Decision code
- APPR
- Date received
- 2003-02-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE LINEAGE ACETABULAR SHELL TO BE USED WITH THE TRANSCEND CERAMIC LINERS.