PMA P010001S022
- Device
- CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S022
- Product code
- MRA
- Decision date
- 2020-01-22
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Firm requests to change the corrosion protection oil for the proof-test machine.
Current openFDA PMA Record#
- Device
- CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S022
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2020-01-22
- Decision code
- OK30
- Date received
- 2019-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Firm requests to change the corrosion protection oil for the proof-test machine.