R3 DELTA CERAMIC HIP SYSTEM

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

FDA Premarket Approval P150030 S001

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 a manufacturing site located at synergy health sterilisation uk ltd. , drayton fields industrial estate, brunel close, daventry northamptonshire, uk nn11 8rb for sterilization of the r3 delta hip system.

DeviceR3 DELTA CERAMIC HIP 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
ApplicantSmith & Nephew, Inc.
Date Received2016-11-07
Decision Date2016-12-21
PMAP150030
SupplementS001
Product CodeMRA
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016

Supplemental Filings

Supplement NumberDateSupplement Type
P150030Original Filing
S028 2022-10-25 30-day Notice
S027 2022-08-31 30-day Notice
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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