REFLECTION CERAMIC ACETABULAR HIP SYSTEM
FDA premarket approval P030022/S027 · decided 2014-09-05
Approval details
- PMA number
- P030022
- Supplement
- S027
- 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
- 2013-11-12
- Decision date
- 2014-09-05
- Days to decision
- 297 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE ADDITION OF A VAPOR DEGREASER AND MACHINING EQUIPMENT.
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