DURALOC OPTION CERAMIC HIP SYSTEM
FDA premarket approval P040023/S020 · decided 2012-04-26
Approval details
- PMA number
- P040023
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURALOC OPTION CERAMIC HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- DePuy Orthopaedics, Inc.
- Date received
- 2012-03-27
- Decision date
- 2012-04-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- CHANGES TO THE STERILE BARRIER PACKAGE SEALING PROCESS USED FOR THE CERAMIC FEMORAL HEADS AND ACETABULAR LINERS.
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