BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S031 · decided 2018-02-22
Approval details
- PMA number
- P040033
- Supplement
- S031
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process 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
- 2017-01-17
- Decision date
- 2018-02-22
- Days to decision
- 401 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for a change to the sterilization parameters that will be used for the BHR components from the previously approved dose range of 25-35 kGy to 25-50 kGy.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.