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P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices.

PMA Application: P040033 S017 (Most recently approved supplement)
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.
All previous 20 supplements
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
Please verify with original source as appropriate.
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