R3 Delta Ceramic Acetabular System

FDA Premarket Approval P150030 S025

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

DeviceR3 Delta Ceramic Acetabular System
Generic NameProsthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
ApplicantSmith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS025 Date Received08/16/2022 Decision Date09/13/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-16
Decision Date2022-09-13
PMAP150030
SupplementS025
Product CodeMRA 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressSmith & Nephew, Inc.
7135 Goodlett Farms Parkway
cordova, TN 38016 PMA NumberP150030 Supplement NumberS025 Date Received08/16/2022 Decision Date09/13/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Introduction Of The Newest Version Of The ZEISS Microscope Used To Verify The Vacuum Plasma Spray (VPS) Coating Process Step

Supplemental Filings

Supplement NumberDateSupplement Type
P150030Original Filing
S026 2022-08-23 30-day Notice
S025 2022-08-16 30-day Notice
S024 2022-08-05 30-day Notice
S023 2022-07-14 30-day Notice
S022 2022-05-23 30-day Notice
S021 2022-04-29 30-day Notice
S020 2022-04-06 30-day Notice
S019 2022-03-07 30-day Notice
S018 2021-11-22 30-day Notice
S017 2021-11-08 Normal 180 Day Track No User Fee
S016
S015 2021-10-13 30-day Notice
S014
S013
S012
S011 2021-06-07 30-day Notice
S010 2021-06-04 30-day Notice
S009 2021-06-04 30-day Notice
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

Device IDPMASupp
00885556499290 P150030 000
00885556498590 P150030 000
00885556498644 P150030 000
00885556498699 P150030 000
00885556498743 P150030 000
00885556498798 P150030 000
00885556498842 P150030 000
00885556498897 P150030 000
00885556498941 P150030 000
00885556498996 P150030 000
00885556499047 P150030 000
00885556499092 P150030 000
00885556499146 P150030 000
00885556499191 P150030 000
00885556499245 P150030 000
00885556498545 P150030 000

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