BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S002 · decided 2007-02-23
Approval details
- PMA number
- P040033
- Supplement
- S002
- 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
- 2006-11-20
- Decision date
- 2007-02-23
- Days to decision
- 95 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 ORTHOPAEDIC LTD. IN WARWICKSHIRE, UNITED KINGDOM, FOR PURCHASING, RECEIVING ACCEPTANCE ACTIVITIES, STORAGE AND RELEASE AND DISPATCH OF PRODUCT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.