PMA P960054S003

Device: S-ROM POLY-DAIL CONSTRAINED LINER
Applicant: Depuy, A Johnson & Johnson Co.
PMA number: P960054
Supplement: S003
Product code: KWZ
Decision date: 1999-12-22
Generic name: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Approval order statement: Approva for the cleaning and packaging site located at DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork. Ireland and the sterilization facility located at ISOTRON plc, Marcus Close, Tilehurst, Reading, Berkshire FG30 4EA, England.

Current openFDA PMA Record#

Device: S-ROM POLY-DAIL CONSTRAINED LINER
Applicant: Depuy, A Johnson & Johnson Co.
PMA number: P960054
Supplement: S003
Product code: KWZ
Generic name: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Decision date: 1999-12-22
Decision code: APPR
Date received: 1999-08-10
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approva for the cleaning and packaging site located at DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork. Ireland and the sterilization facility located at ISOTRON plc, Marcus Close, Tilehurst, Reading, Berkshire FG30 4EA, England.