Tags
BHR, Food & Drug Administration, Hip Replacement, hip resurfacing, Medical device, NephewSmith, Patient, Smith & Nephew, UNited States
P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices.
| Attribute | Value |
|---|---|
| Trade Name | BIRMINGHAM HIP RESURFACING SYSTEM (BHR) |
| Generic Name | TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL |
| Applicant | SMITH & NEPHEW, INC. |
| PMA Number | P040033 |
| Supplement Number | S017 |
| Date Received | Oct 18, 2010 |
| Decision Date | Oct 14, 2011 |
| Product Code | NXT |
| Advisory Committee | OR |
| Supplement Type | 135 REVIEW TRACK FOR 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | APPROVAL FOR THE ADDITION OF AN ALTERNATIVE SITE FOR THE POROUS COATING PROCESS FOR THE R3 ACETABULAR SHELLS. |
| Trade Name/Applicant | Suppl. Reason/Type | Suppl. No. | Decision Date |
|---|---|---|---|
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH & NEPHEW, INC.
|
30-DAY NOTICE
|
S021 | Jul 27, 2011 |
|
BIRMINGHAM HIP RESURFACING SYSTEM (BHR)
SMITH&NEPHEW ORTHOPAEDICS
|
POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL
NORMAL 180 DAY TRACK NO USER FEE
|
S019 | Apr 01, 2011 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
LABELING CHANGE – INSTRUCTIONS
SPECIAL(IMMEDIATE TRACK)
|
S020 | Mar 16, 2011 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
LABELING CHANGE – INSTRUCTIONS
SPECIAL(IMMEDIATE TRACK)
|
S016 | Oct 13, 2010 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS – COMPONENT
REAL-TIME PROCESS
|
S015 | Mar 09, 2010 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
PROCESS CHANGE: MANUFACTURING
135 REVIEW TRACK FOR 30-DAY NOTICE
|
S013 | Dec 31, 2009 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
LABELING CHANGE – OTHER
SPECIAL(IMMEDIATE TRACK)
|
S014 | Dec 11, 2009 |
|
BIRMINGHAM HIP RESURFACING SYSTEM, REFLECTION CERAMIC ACETABULAR HIP SYSTEM
SMITH & NEPHEW, INC.
|
PROCESS CHANGE: MANUFACTURING
135 REVIEW TRACK FOR 30-DAY NOTICE
|
S012 | Oct 07, 2009 |
|
BIRMINGHAM HIP RESURFACING SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
LABELING CHANGE – INSTRUCTIONS
REAL-TIME PROCESS
|
S011 | Jun 09, 2009 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS – COMPONENT
REAL-TIME PROCESS
|
S010 | Feb 13, 2009 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
LABELING CHANGE – INSTRUCTIONS
REAL-TIME PROCESS
|
S008 | Jan 12, 2009 |
|
BIRMINGHAM HIP RESURFACING SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
PROCESS CHANGE: MANUFACTURING
30-DAY NOTICE
|
S009 | Dec 18, 2008 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS – COMPONENT
NORMAL 180 DAY TRACK
|
S006 | Nov 13, 2008 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
LOCATION CHANGE: MANUFACTURER
NORMAL 180 DAY TRACK NO USER FEE
|
S003 | Oct 14, 2008 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
PROCESS CHANGE: MANUFACTURING
135 REVIEW TRACK FOR 30-DAY NOTICE
|
S007 | Jun 20, 2008 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL
NORMAL 180 DAY TRACK NO USER FEE
|
S004 | Oct 01, 2007 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS – COMPONENT
REAL-TIME PROCESS
|
S005 | Jun 27, 2007 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
LOCATION CHANGE: MANUFACTURER
NORMAL 180 DAY TRACK NO USER FEE
|
S002 | Feb 23, 2007 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
DESIGN CHANGE – MINOR
REAL-TIME PROCESS
|
S001 | Oct 13, 2006 |
|
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
SMITH&NEPHEW ORTHOPAEDICS
|
May 09, 2006 |
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Related articles
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