PMA P010001S018
- Device
- Transcend Hip Articulation System
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S018
- Product code
- MRA
- Decision date
- 2018-04-20
- 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
- Change in supplier and temperature for one of the manufacturing steps.
Current openFDA PMA Record#
- Device
- Transcend Hip Articulation System
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S018
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2018-04-20
- Decision code
- OK30
- Date received
- 2018-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in supplier and temperature for one of the manufacturing steps.