ANTHOLOGY FEMORAL STEMS
FDA premarket approval P030022/S033 · decided 2016-06-08
Approval details
- PMA number
- P030022
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANTHOLOGY FEMORAL STEMS
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2015-07-27
- Decision date
- 2016-06-08
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for a manufacturing site located at Orchid Detroit 23149 Commerce Drive, Farmington Hills, MI 48335.
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