- Device
- PINNACLE COMPLETE ACETABULAR HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P090002
- Supplement
- S003
- Product code
- OVO
- Generic name
- Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
- Decision date
- 2012-04-26
- Decision code
- OK30
- Date received
- 2012-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE STERILE BARRIER PACKAGE SEALING PROCESS USED FOR THE CERAMIC FEMORAL HEADS AND ACETABULAR LINERS.