PMA P150030S043

Device: R3TM delta Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S043
Product code: MRA
Decision date: 2024-09-13
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: updates to product labelling, including Instructions for Use (IFU) and packaging labels, to include additional symbols and MR safety information for the R3 DELTA CERAMIC HIP SYSTEM implants

Current openFDA PMA Record#

Device: R3TM delta Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S043
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2024-09-13
Decision code: APPR
Date received: 2024-08-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: updates to product labelling, including Instructions for Use (IFU) and packaging labels, to include additional symbols and MR safety information for the R3 DELTA CERAMIC HIP SYSTEM implants