FDA.reportPublic FDA data

SIENTRA, INC

Matched from indexed company URL: Sientra, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16511893001628772SIENTRA, INC1N2020-04-25420 S Fairview Ave Ste 200 Santa Barbara CA US 93117
30160509353016050935Sientra, Inc.1N2020-04-259900-A S 57th Street Franklin WI US 53132

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00812790023196SIENTRA Nasal Implant - Nasal Implant, 'L', Solid Silicone White, 25/50 Sh A, Smooth, 60 mm888-708-0808customer.experience@sientra.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
804451278755382P070004SIENTRA SILICONE GEL BREAST IMPLANTSFTR2012-03-09
2359701278755382P070004SIENTRA SILICONE GEL BREAST IMPLANTSFTR2012-03-09
804451218084858K984106MAMMARY SIZER, MAMMARY PROTHESIS SIZERMRD1999-02-12
804451333857045K982067MAGNETIC PORT SILICONE TISSUE EXPANDERLCJ1998-07-13
804451374486015K981852SILIMED TISSUE EXPANDERLCJ1998-08-05
804451055959099K981851SILIMED SILICONE CARVING BLOCKMIB1998-07-09
804452054606752K981850SILIMED CHIN IMPLANTSFWP1998-07-09
804451918699619K981835SILIMED MALAR IMPLANTLZK1998-07-09
804451166110722K981833SILIMED NASAL L SHAPED IMPLANTFZE1998-06-26
804451050143975K980221SILIMED NASAL RETAINERLYA1998-04-02
804451425255034K974482SILIMED GLUTEAL IMPLANTMIB1998-02-24
804451522190728K974480SILIMED CALF IMPLANTMIB1998-02-24
804451127188287K974479SILIMED VAGINAL STENTKXP1998-08-05
804451588657376K974209SILICONE TISSUE/INFLATABLE TISSUE EXPANDERLCJ1998-02-06
804451488355529K140383ALLOX2 TISSUE EXPANDERSLCJ2014-10-28
804451058839664K070303SILICONE TISSUE EXPANDERLCJ2007-06-22
804451956164763K042054SILIMED PECTORAL IMPLANTMIB2005-02-23
804451621184934
804451918003033
804451938762845

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCJ52014-10-28
MIB42005-02-23
FTR22012-03-09
MRD11999-02-12
KXP11998-08-05
LZK11998-07-09
FWP11998-07-09
FZE11998-06-26
LYA11998-04-02

PMA#

Sientra OPUS® Silicone Gel Breast Implants

2022-07-20

SIENTRA, INC6769 Hollister Avenuesuite 201santa Barbara, CA 93117 PMA NumberP070004 Supplement NumberS037 Date Received06/17/2022 Decision Date07/20/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement ...

Sientra OPUS Silicone Gel Breast Implants

2022-07-05

SIENTRA, INC6769 Hollister Avenuesuite 201santa Barbara, CA 93117 PMA NumberP070004 Supplement NumberS035 Date Received04/08/2022 Decision Date07/05/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplem...

Sientra OPUS Silicone Gel Breast Implants

2022-03-02

SIENTRA, 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 ...

PMN#

GUDID#

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