BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S003 · decided 2008-10-14
Approval details
- PMA number
- P040033
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2006-12-26
- Decision date
- 2008-10-14
- Days to decision
- 658 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SMITH & NEPHEW ORTHOPAEDICS LTD., WARWICKSHIRE, UNITED KINGDOM, TO PERFORM FINAL MACHINING, AND A MANUFACTURING SITE LOCATED AT LPE MEDICAL LTD., HAMPSHIRE, UNITED KINGDOM.
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