REFLECTION CERAMIC ACETABULAR HIP SYSTEM
FDA premarket approval P030022/S006 · decided 2007-10-12
Approval details
- PMA number
- P030022
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2007-05-31
- Decision date
- 2007-10-12
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE ELIMINATION OF STERILIZATION CYCLE 204, A REDUCTION IN THE REQUIRED NUMBER OF PROCESS CHALLENGE DEVICES (PCD), THE INCREASE IN THE LENGTH OF PCD TUBING, A REDUCTION IN THE NUMBER OF PCDS THAT NEED TO BE TESTED WHEN SOME OF THE PCDS ARE DAMAGED OR LOST, AND A CHANGE IN THE PLACEMENT PATTERN FOR BIOLOGICAL INDICATORS.
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