REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
FDA premarket approval P030022/S017 · decided 2011-10-14
Approval details
- PMA number
- P030022
- Supplement
- S017
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2010-10-18
- Decision date
- 2011-10-14
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATIVE SITE FOR THE POROUS COATING PROCESS FOR THE R3 ACETABULAR SHELLS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.