C2A-TAPER ACETABULAR SYSTEM
FDA premarket approval P050009/S001 · decided 2006-02-01
Approval details
- PMA number
- P050009
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- C2A-TAPER ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Biomet, Inc.
- Date received
- 2006-01-10
- Decision date
- 2006-02-01
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC. FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.
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