PMA P050039S007
- Device
- EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S007
- Product code
- MRA
- Decision date
- 2012-04-27
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- APPROVAL FOR USE OF AN ADDITIONAL PACKAGE SEALER FOR THE ACETABULAR LINER AND FEMORAL HEAD STERILE BARRIER PACKAGING PROCESSES.
Current openFDA PMA Record#
- Device
- EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S007
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2012-04-27
- Decision code
- APPR
- Date received
- 2011-10-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR USE OF AN ADDITIONAL PACKAGE SEALER FOR THE ACETABULAR LINER AND FEMORAL HEAD STERILE BARRIER PACKAGING PROCESSES.