PMA P090002S005

Device: PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P090002
Supplement: S005
Product code: OVO
Decision date: 2012-09-06
Generic name: Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Approval order statement: APPROVAL FOR THE ADDITION OF AN INDEPENDENT INSPECTOR TO PERFORM VISUAL CHECK OF THE S-ROM FEMORAL STEM COMPONENT STERILE PACKAGING.

Current openFDA PMA Record#

Device: PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P090002
Supplement: S005
Product code: OVO
Generic name: Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Decision date: 2012-09-06
Decision code: APPR
Date received: 2012-08-03
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF AN INDEPENDENT INSPECTOR TO PERFORM VISUAL CHECK OF THE S-ROM FEMORAL STEM COMPONENT STERILE PACKAGING.