R3 Biolox delta Ceramic Acetabular System

FDA Premarket Approval P150030 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

Approval of a revised protocol for the post-approval study protocol.

DeviceR3 Biolox delta Ceramic Acetabular System
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantSmith & Nephew, Inc.
Date Received2020-07-22
Decision Date2020-08-21
PMAP150030
SupplementS008
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016

Supplemental Filings

Supplement NumberDateSupplement Type
P150030Original Filing
S008 2020-07-22 Normal 180 Day Track No User Fee
S007 2019-05-09 30-day Notice
S006 2018-11-21 Real-time Process
S005 2018-08-22 Normal 180 Day Track No User Fee
S004 2017-11-24 30-day Notice
S003 2017-08-17 Normal 180 Day Track No User Fee
S002 2017-05-04 30-day Notice
S001 2016-11-07 Normal 180 Day Track No User Fee

NIH GUDID Devices

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