REFLECTION CERAMIC HIP SYSTEM (RCHS)
FDA premarket approval P030022/S024 · decided 2013-08-06
Approval details
- PMA number
- P030022
- Supplement
- S024
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- REFLECTION CERAMIC HIP SYSTEM (RCHS)
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2013-03-21
- Decision date
- 2013-08-06
- Days to decision
- 138 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR A SOFTWARE CHANGE TO ANALYZE THE STIKTITE POROUS COATINGS.
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