EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
FDA premarket approval P050039/S007 · decided 2012-04-27
Approval details
- PMA number
- P050039
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2011-10-07
- Decision date
- 2012-04-27
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR USE OF AN ADDITIONAL PACKAGE SEALER FOR THE ACETABULAR LINER AND FEMORAL HEAD STERILE BARRIER PACKAGING PROCESSES.
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