DEPUY DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM
FDA premarket approval P040023/S018 · decided 2012-03-08
Approval details
- PMA number
- P040023
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DEPUY DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- DePuy Orthopaedics, Inc.
- Date received
- 2011-09-16
- Decision date
- 2012-03-08
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE FOR THE DURALOC OPTION CERAMIC HIP SYSTEM.
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