PMA P010001S003
- Device
- CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S003
- Product code
- MRA
- Decision date
- 2008-07-03
- 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 A MANUFACTURING SITE LOCATED IN MARKTREDWITZ, GERMANY.
Current openFDA PMA Record#
- Device
- CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Applicant
- Ceramtec GmbH
- PMA number
- P010001
- Supplement
- S003
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2008-07-03
- Decision code
- APPR
- Date received
- 2006-03-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN MARKTREDWITZ, GERMANY.