PMA P010001S019
- Device
- TRANSCEND Hip Articulation System
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S019
- Product code
- MRA
- Decision date
- 2019-03-06
- 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
- Addition of a new grinding machine for the TRANSCEND Hip Articulation System.
Current openFDA PMA Record#
- Device
- TRANSCEND Hip Articulation System
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S019
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2019-03-06
- Decision code
- OK30
- Date received
- 2019-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new grinding machine for the TRANSCEND Hip Articulation System.