CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
FDA premarket approval P010001/S001 · decided 2003-04-04
Approval details
- PMA number
- P010001
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Ceramtec GmbH
- Date received
- 2003-02-20
- Decision date
- 2003-04-04
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- APPROVAL FOR THE ADDITION OF THE LINEAGE ACETABULAR SHELL TO BE USED WITH THE TRANSCEND CERAMIC LINERS.
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