CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
FDA premarket approval P010001/S003 · decided 2008-07-03
Approval details
- PMA number
- P010001
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2006-03-22
- Decision date
- 2008-07-03
- Days to decision
- 834 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN MARKTREDWITZ, GERMANY.
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