REFLECTION CERAMIC HIP SYSTEM
FDA premarket approval P030022/S023 · decided 2013-08-01
Approval details
- PMA number
- P030022
- Supplement
- S023
- 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
- 2013-02-19
- Decision date
- 2013-08-01
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR TWO CHANGES MADE BY AT A RAW MATERIAL SUPPLIER: 1) THE FORGING PROCESS OF THE R3 ACETABULAR SHELLS; AND 2) THE BLAST MEDIA USED FOR AN IN PROCESS BLAST OPERATION FOR THE SYNERGY FEMORAL STEMS.
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