TRILOGY AB ACETABULAR SYSTEM

FDA Premarket Approval P040048 S001

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 manufacturing site located at zimmer, inc. , warsaw, indiana for design control, final packaging and labeling of the ceramic acetabular shell components and approval for a sterilization site located at sterigenics us llc, westerville, ohio.

DeviceTRILOGY AB ACETABULAR SYSTEM
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantZIMMER, INC.
Date Received2006-10-12
Decision Date2006-12-28
PMAP040048
SupplementS001
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708

Supplemental Filings

Supplement NumberDateSupplement Type
P040048Original Filing
S017 2012-04-06 135 Review Track For 30-day Notice
S016 2012-01-12 30-day Notice
S015 2011-06-14 Normal 180 Day Track No User Fee
S014 2011-05-02 Special (immediate Track)
S013
S012 2009-11-24 30-day Notice
S011 2009-11-23 30-day Notice
S010 2009-11-09 30-day Notice
S009 2009-09-14 Normal 180 Day Track No User Fee
S008 2009-05-11 Normal 180 Day Track No User Fee
S007
S006
S005 2008-04-17 30-day Notice
S004 2008-04-16 135 Review Track For 30-day Notice
S003 2007-11-30 135 Review Track For 30-day Notice
S002 2007-01-26 135 Review Track For 30-day Notice
S001 2006-10-12 Normal 180 Day Track No User Fee

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