NOVATION CERAMIC ARTICULATION HIP SYSTEM
FDA premarket approval P050039/S004 · decided 2010-12-09
Approval details
- PMA number
- P050039
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- NOVATION CERAMIC ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2009-09-15
- Decision date
- 2010-12-09
- Days to decision
- 450 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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