REFLECTION CERAMIC ACETABULAR HIP SYSTEM

FDA Premarket Approval P030022 S036

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 for a labeling change for the reflection ceramic acetabular hip system which also includes the r3 ceramic acetabular hip system.

DeviceREFLECTION CERAMIC ACETABULAR HIP SYSTEM
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantSmith & Nephew, Inc.
Date Received2016-06-23
Decision Date2016-07-22
PMAP030022
SupplementS036
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016

Supplemental Filings

Supplement NumberDateSupplement Type
P030022Original Filing
S049 2022-07-14 30-day Notice
S048 2022-06-06 30-day Notice
S047 2022-05-23 30-day Notice
S046
S045 2017-11-24 30-day Notice
S044 2017-07-19 30-day Notice
S043 2017-05-04 30-day Notice
S042 2016-12-19 Special (immediate Track)
S041 2016-11-23 Special (immediate Track)
S040 2016-10-17 Special (immediate Track)
S039 2016-09-19 Normal 180 Day Track No User Fee
S038 2016-07-15 Normal 180 Day Track No User Fee
S037 2016-07-07 Real-time Process
S036 2016-06-23 Special (immediate Track)
S035 2015-12-28 30-day Notice
S034 2015-11-24 30-day Notice
S033 2015-07-27 Normal 180 Day Track No User Fee
S032 2015-07-27 Real-time Process
S031 2014-09-12 30-day Notice
S030 2014-05-02 30-day Notice
S029 2013-12-20 30-day Notice
S028 2013-12-18 30-day Notice
S027 2013-11-12 135 Review Track For 30-day Notice
S026 2013-09-25 30-day Notice
S025 2013-06-06 Real-time Process
S024 2013-03-21 135 Review Track For 30-day Notice
S023 2013-02-19 135 Review Track For 30-day Notice
S022 2012-08-10 30-day Notice
S021 2012-02-01 135 Review Track For 30-day Notice
S020 2011-12-21 30-day Notice
S019 2011-07-14 30-day Notice
S018 2011-04-29 30-day Notice
S017 2010-10-18 135 Review Track For 30-day Notice
S016 2010-07-07 Real-time Process
S015 2010-07-02 135 Review Track For 30-day Notice
S014 2010-05-12 30-day Notice
S013 2009-08-12 30-day Notice
S012 2009-07-22 135 Review Track For 30-day Notice
S011 2008-11-28 30-day Notice
S010 2008-09-10 Normal 180 Day Track No User Fee
S009 2008-02-06 135 Review Track For 30-day Notice
S008 2007-10-02 Normal 180 Day Track
S007
S006 2007-05-31 135 Review Track For 30-day Notice
S005 2007-05-01 135 Review Track For 30-day Notice
S004 2006-04-20 135 Review Track For 30-day Notice
S003 2006-04-20 135 Review Track For 30-day Notice
S002 2006-02-14 135 Review Track For 30-day Notice
S001 2005-09-02 Real-time Process

NIH GUDID Devices

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