R3TM delta Ceramic Acetabular System
FDA premarket approval P150030/S014 · decided 2022-09-09
Approval details
- PMA number
- P150030
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- R3TM delta Ceramic Acetabular System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2021-10-13
- Decision date
- 2022-09-09
- Days to decision
- 331 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for an alternative process to mask the device during the Vacuum Plasma Spray (VPS) coating process for the POLARSTEM Stems.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.