OSTEO CERAMIC HIP
FDA premarket approval P810048/S011 · decided 1987-07-01
Approval details
- PMA number
- P810048
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OSTEO CERAMIC HIP
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 1986-10-30
- Decision date
- 1987-07-01
- Days to decision
- 244 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
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