Sientra Opus Silicone Gel Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled

FDA Premarket Approval P070004 S028

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

Addition of four laminar flow hoods

DeviceSientra Opus Silicone Gel Breast Implants
Classification NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantSIENTRA, INC
Date Received2019-10-22
Decision Date2019-11-21
PMAP070004
SupplementS028
Product CodeFTR
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIENTRA, INC 6769 Hollister Avenue suite 201 santa Barbara, CA 93117

Supplemental Filings

Supplement NumberDateSupplement Type
P070004Original Filing
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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