REFLECTION CERAMIC ACETABULAR SYSTEM
FDA premarket approval P030022/S002 · decided 2006-06-16
Approval details
- PMA number
- P030022
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REFLECTION CERAMIC ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2006-02-14
- Decision date
- 2006-06-16
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR MANUFACTURING PROCESS CHANGES TO BE MADE BY CERAMTEC, INC., FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.
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