PMA P150030S044

Device: R3TM DELTA CERAMIC ACETABULAR SYSTEM
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S044
Product code: MRA
Decision date: 2024-09-10
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: to reduce the frequency of endotoxin testing for the R3 Shells at Smith & Nephew Operations Malaysia (SNOM)

Current openFDA PMA Record#

Device: R3TM DELTA CERAMIC ACETABULAR SYSTEM
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S044
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2024-09-10
Decision code: OK30
Date received: 2024-08-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to reduce the frequency of endotoxin testing for the R3 Shells at Smith & Nephew Operations Malaysia (SNOM)