R3 Delta Ceramic Hip System
FDA premarket approval P150030/S036 · decided 2024-04-29
Approval details
- PMA number
- P150030
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- R3 Delta Ceramic Hip System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2023-09-11
- Decision date
- 2024-04-29
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for the addition of an alternative manufacturing facility (Smith And Nephew Operations Sdn. Bhd PMT 797, Persiaran Cassia Selatan 8 Taman Perindustrian Batu Kawan, Bandar Cassia Penang Pulau Pinang, Malaysia 14110) for R3 Acetabular Shells which are approved for use as part of the P150030 - R3 Delta Ceramic Acetabular System as well as an additional vendor for sterilization (Synergy Sterilisation(M) Sdn. Bhd., Plot 203, Kuala Ketil Industrial Estate, Kuala Ketil Kedah, Malaysia 09300)
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