CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
FDA premarket approval P010001/S009 · decided 2012-04-19
Approval details
- PMA number
- P010001
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Ceramtec GmbH
- Date received
- 2011-03-17
- Decision date
- 2012-04-19
- Days to decision
- 399 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- APPROVAL FOR USE OF ADDITIONAL AND REPLACEMENT MACHINES FOR GRINDING, POLISHING AND DIMENSIONAL INSPECTION.
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