PMA P090002

Device: PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P090002
Supplement: S009
Product code: OVO
Decision date: 2013-08-06
Generic name: Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Approval order statement: APPROVAL FOR CHANGES TO THE PROCESS PARAMETERS FOR AN EXISTING PACKAGE SEALER AND ADDITION OF AN ALTERNATE PACKAGE SEALER.

Current openFDA PMA Record#

Device: PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P090002
Supplement: S009
Product code: OVO
Generic name: Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Decision date: 2013-08-06
Decision code: APPR
Date received: 2013-03-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR CHANGES TO THE PROCESS PARAMETERS FOR AN EXISTING PACKAGE SEALER AND ADDITION OF AN ALTERNATE PACKAGE SEALER.