CERAMIC TRANSCEND HIP ARTICULATION SYSTEM

FDA Premarket Approval P010001 S022

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

Firm requests to change the corrosion protection oil for the proof-test machine.

DeviceCERAMIC TRANSCEND HIP ARTICULATION SYSTEM
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantCERAMTEC GMBH
Date Received2019-12-23
Decision Date2020-01-22
PMAP010001
SupplementS022
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CERAMTEC GMBH ceramtec-platz 1-9 73207 plochingen 73207

Supplemental Filings

Supplement NumberDateSupplement Type
P010001Original Filing
S022 2019-12-23 30-day Notice
S021
S020 2019-07-11 30-day Notice
S019 2019-01-28 30-day Notice
S018 2018-03-19 30-day Notice
S017 2016-01-28 30-day Notice
S016 2016-01-27 30-day Notice
S015 2016-01-27 30-day Notice
S014 2015-10-30 30-day Notice
S013 2015-05-29 30-day Notice
S012 2015-05-15 30-day Notice
S011 2015-02-06 30-day Notice
S010 2011-06-10 135 Review Track For 30-day Notice
S009 2011-03-17 135 Review Track For 30-day Notice
S008 2011-02-04 30-day Notice
S007 2010-04-21 135 Review Track For 30-day Notice
S006 2010-04-21 135 Review Track For 30-day Notice
S005 2010-03-22 135 Review Track For 30-day Notice
S004 2007-07-18 30-day Notice
S003 2006-03-22 Normal 180 Day Track No User Fee
S002 2005-07-25 135 Review Track For 30-day Notice
S001 2003-02-20 Normal 180 Day Track

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