NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS)
FDA premarket approval P050039/S018 · decided 2015-12-30
Approval details
- PMA number
- P050039
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS)
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2015-12-09
- Decision date
- 2015-12-30
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- ADDITION OF CERAMTECH'S MARKTREDWITZ FACILITY FOR THE USE OF THE HOT ISOSTATIC PRESSURE (HIP) PROCESS.
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