PMA P150030S027

Device: R3 DELTA CERAMIC ACETABULAR SYSTEM
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S027
Product code: MRA
Decision date: 2022-09-29
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Modification of the tab removal process of the SYNERGY stems at a supplier by replacing the current milling machines with a belt grinding machine.

Current openFDA PMA Record#

Device: R3 DELTA CERAMIC ACETABULAR SYSTEM
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S027
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-09-29
Decision code: OK30
Date received: 2022-08-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification of the tab removal process of the SYNERGY stems at a supplier by replacing the current milling machines with a belt grinding machine.