REFLECTION CERAMIC HIP SYSTEM
FDA premarket approval P030022/S004 · decided 2007-05-04
Approval details
- PMA number
- P030022
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REFLECTION CERAMIC HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2006-04-20
- Decision date
- 2007-05-04
- Days to decision
- 379 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL OR THE ADDITION OF ANOTHER ETO STERILIZATION PROCESS THAT UTILIZES A 4 HOUR EO EXPOSURE TIME COMPARED TO THE PREVIOUS 2 HOUR EO EXPOSURE TIME, AS WELL AS A CHANGE IN THE ACCEPTABLE NUMBER OF BIOINDICATORS TO REFLECT CURRENT AAMI STANDARDS.
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