REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
FDA premarket approval P030022/S018 · decided 2011-05-26
Approval details
- PMA number
- P030022
- Supplement
- S018
- Supplement type
- 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
- 2011-04-29
- Decision date
- 2011-05-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- USE OF AN ALTERNATIVE MANUFACTURING SUPPLIER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.