C2A-TAPER ACETABULAR SYSTEM

FDA Premarket Approval P050009 S002

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

Replacement of the previous software system with an image analyzer software and the revision of the porous coating test procedures.

DeviceC2A-TAPER ACETABULAR SYSTEM
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantBiomet, Inc.
Date Received2006-05-19
Decision Date2006-06-16
PMAP050009
SupplementS002
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Biomet, Inc. p.o. Box 587 warsaw, IN 46581-0587

Supplemental Filings

Supplement NumberDateSupplement Type
P050009Original Filing
S009 2010-02-16 Normal 180 Day Track No User Fee
S008
S007 2009-02-19 30-day Notice
S006
S005 2007-11-02 30-day Notice
S004 2007-09-27 135 Review Track For 30-day Notice
S003
S002 2006-05-19 30-day Notice
S001 2006-01-10 30-day Notice

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