PINNACLE COMPLETE ACETABULAR HIP SYSTEM

FDA Premarket Approval P090002 S009

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 changes to the process parameters for an existing package sealer and addition of an alternate package sealer.

DevicePINNACLE COMPLETE ACETABULAR HIP SYSTEM
Generic NameProsthesis, Hip, Semi-constrained, Ceramic-on-metal Articulation
ApplicantDEPUY ORTHOPAEDICS, INC.
Date Received2013-03-12
Decision Date2013-08-06
PMAP090002
SupplementS009
Product CodeOVO 
Advisory CommitteeOrthopedic
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DEPUY ORTHOPAEDICS, INC. p.o Box 988 700 Orthopaedic Drive warsaw, IN 46581-0988

Supplemental Filings

Supplement NumberDateSupplement Type
P090002Original Filing
S009 2013-03-12 135 Review Track For 30-day Notice
S008
S007 2012-11-28 Special (immediate Track)
S006 2012-10-25 30-day Notice
S005 2012-08-03 Special (immediate Track)
S004 2012-05-18 30-day Notice
S003 2012-03-27 30-day Notice
S002 2012-01-19 Real-time Process
S001 2011-09-07 Normal 180 Day Track No User Fee

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