Sientra OPUS Silicone Gel Breast Implants

FDA Premarket Approval P070004 S033

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 changes to the patient and physician labeling including a boxed warning and a patient decision checklist.

DeviceSientra OPUS Silicone Gel Breast Implants
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantSIENTRA, INC
Date Received2021-08-06
Decision Date2021-10-27
PMAP070004
SupplementS033
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SIENTRA, INC 6769 Hollister Avenue suite 201 santa Barbara, CA 93117
Approval Order:Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P070004Original Filing
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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