CERAMIC TRANSCEND ARTICULATION SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented

FDA Premarket Approval P030027 S008

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

Addition of ceramtech's marktredwitz facility for the use of the hot isostatic pressure (hip) process.

DeviceCERAMIC TRANSCEND ARTICULATION SYSTEM
Classification NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantMicroPort Orthopedics Inc.
Date Received2015-12-10
Decision Date2015-12-30
PMAP030027
SupplementS008
Product CodeMRA
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MicroPort Orthopedics Inc. 5677 Airline Rd arlington, TN 38002-0000

Supplemental Filings

Supplement NumberDateSupplement Type
P030027Original Filing
S009 2016-03-11 Normal 180 Day Track No User Fee
S008 2015-12-10 30-day Notice
S007 2013-04-26 135 Review Track For 30-day Notice
S006 2013-01-22 135 Review Track For 30-day Notice
S005 2012-02-08 Normal 180 Day Track No User Fee
S004 2007-12-28 135 Review Track For 30-day Notice
S003
S002 2006-03-08 Real-time Process
S001 2006-01-30 30-day Notice

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