R3 DELTA CERAMIC ACETABULAR SYSTEM
FDA premarket approval P150030/S040 · decided 2024-06-27
Approval details
- PMA number
- P150030
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- R3 DELTA CERAMIC ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2024-05-31
- Decision date
- 2024-06-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- to introduce a new production aid for the wastewater treatment in the drag finishing process for POLARSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.