PMA P090002S007
- Device
- PINNACLE COMPLETE ACETABULAR HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P090002
- Supplement
- S007
- Product code
- OVO
- Decision date
- 2012-12-21
- Generic name
- Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
- Approval order statement
- APPROVAL FOR CHANGES TO THE PRODUCT LABELING/ INFORMATION FOR USE FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- PINNACLE COMPLETE ACETABULAR HIP SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P090002
- Supplement
- S007
- Product code
- OVO
- Generic name
- Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
- Decision date
- 2012-12-21
- Decision code
- APPR
- Date received
- 2012-11-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE PRODUCT LABELING/ INFORMATION FOR USE FOR THE DEVICE.