EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
FDA premarket approval P050039/S005 · decided 2011-03-31
Approval details
- PMA number
- P050039
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2011-03-11
- Decision date
- 2011-03-31
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR LABELING CHANGES WHICH ADD STRENGTHENING LANGUAGE TO THE FEMORAL STEM SURGICAL TECHNIQUE MANUALS.
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