DURALOC OPTION CERAMIC HIP SYSTEM

FDA Premarket Approval P040023 S021

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the post-approval study protocol.

DeviceDURALOC OPTION CERAMIC HIP SYSTEM
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantDEPUY ORTHOPAEDICS, INC.
Date Received2012-04-18
Decision Date2012-06-15
PMAP040023
SupplementS021
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address DEPUY ORTHOPAEDICS, INC. 700 Orthopaedic Drive warsaw, IN 46581-0988

Supplemental Filings

Supplement NumberDateSupplement Type
P040023Original Filing
S025 2012-10-25 30-day Notice
S024 2012-08-03 Special (immediate Track)
S023
S022 2012-05-18 30-day Notice
S021 2012-04-18 Normal 180 Day Track No User Fee
S020 2012-03-27 30-day Notice
S019 2011-11-09 Special (immediate Track)
S018 2011-09-16 Real-time Process
S017
S016 2009-12-11 135 Review Track For 30-day Notice
S015 2009-12-02 135 Review Track For 30-day Notice
S014 2009-10-19 Normal 180 Day Track No User Fee
S013 2008-11-26 30-day Notice
S012 2008-11-18 Normal 180 Day Track No User Fee
S011 2008-08-19 135 Review Track For 30-day Notice
S010 2007-10-12 30-day Notice
S009 2007-07-02 Normal 180 Day Track No User Fee
S008 2006-09-19 Special (immediate Track)
S007 2006-05-04 Special (immediate Track)
S006 2006-05-02 135 Review Track For 30-day Notice
S005
S004 2006-02-23 Normal 180 Day Track No User Fee
S003 2005-11-21 Special (immediate Track)
S002 2005-11-10 Special (immediate Track)
S001 2005-09-02 135 Review Track For 30-day Notice

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