REFLECTION CERAMIC ACETABULAR HIP (RCHS)
FDA premarket approval P030022/S014 · decided 2010-06-11
Approval details
- PMA number
- P030022
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REFLECTION CERAMIC ACETABULAR HIP (RCHS)
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2010-05-12
- Decision date
- 2010-06-11
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- CHANGE IN THE HA COATING VENDOR.
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