Sientra OPUS Silicone Gel Breast Implants

FDA Premarket Approval P070004 S034

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

DeviceSientra OPUS Silicone Gel Breast Implants
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantSIENTRA, INC6769 Hollister Avenuesuite 201santa Barbara, CA 93117 PMA NumberP070004 Supplement NumberS034 Date Received01/31/2022 Decision Date03/02/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-01-31
Decision Date2022-03-02
PMAP070004
SupplementS034
Product CodeFTR 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressSIENTRA, INC
6769 Hollister Avenue
suite 201
santa Barbara, CA 93117 PMA NumberP070004 Supplement NumberS034 Date Received01/31/2022 Decision Date03/02/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Addition Of A Gel Dispersion Viscosity Assessment Method, ‘Percent Solids Method’ To Provide Supplementary Dispersion Viscosity Information During The Manufacture Of Sientra Silicone Gel Breast Implants

Supplemental Filings

Supplement NumberDateSupplement Type
P070004Original Filing
S037 2022-06-17 30-day Notice
S036
S035 2022-04-08 Real-time Process
S034 2022-01-31 30-day Notice
S033 2021-08-06 Normal 180 Day Track
S032
S031 2020-03-04 30-day Notice
S030
S029
S028 2019-10-22 30-day Notice
S027
S026 2019-10-07 30-day Notice
S025 2019-10-03 30-day Notice
S024 2019-10-03 30-day Notice
S023
S022 2019-09-30 30-day Notice
S021 2019-09-30 30-day Notice
S020 2019-09-16 30-day Notice
S019
S018
S017
S016
S015 2019-01-07 Real-time Process
S014 2017-12-21 30-day Notice
S013 2017-12-14 135 Review Track For 30-day Notice
S012 2017-12-11 30-day Notice
S011 2017-11-06 Special (immediate Track)
S010 2017-06-05 Normal 180 Day Track No User Fee
S009 2017-03-15 Normal 180 Day Track No User Fee
S008 2015-03-23 Real-time Process
S007 2013-12-12 30-day Notice
S006 2013-09-19 Real-time Process
S005
S004 2012-04-09 Normal 180 Day Track No User Fee
S003 2012-03-30 Normal 180 Day Track No User Fee
S002 2012-03-30 Normal 180 Day Track No User Fee
S001 2012-03-30 Normal 180 Day Track No User Fee

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