BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S021 · decided 2011-07-27
Approval details
- PMA number
- P040033
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2011-06-28
- Decision date
- 2011-07-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- USE OF A NEW DEGREASING SYSTEM AT A CONTRACT MANUFACTURER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.