Ideal Implant Saline-filled Breast Implant

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Premarket Approval P120011 S010

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 labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (bia-alcl).

DeviceIdeal Implant Saline-filled Breast Implant
Classification NameProsthesis, Breast, Inflatable, Internal, Saline
Generic NameProsthesis, Breast, Inflatable, Internal, Saline
ApplicantIDEALIMPLANT
Date Received2017-10-23
Decision Date2017-11-17
PMAP120011
SupplementS010
Product CodeFWM
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address IDEALIMPLANT 14881 Quorum Drive Suite 925 dallas, TX 75254

Supplemental Filings

Supplement NumberDateSupplement Type
P120011Original Filing
S024 2021-12-22 30-day Notice
S023
S022 2021-05-27 Normal 180 Day Track No User Fee
S021 2020-11-03 135 Review Track For 30-day Notice
S020 2020-07-02 30-day Notice
S019
S018 2020-03-17 30-day Notice
S017
S016 2019-06-21 30-day Notice
S015
S014
S013 2018-07-25 30-day Notice
S012 2018-06-11 Real-time Process
S011 2018-06-08 30-day Notice
S010 2017-10-23 Special (immediate Track)
S009 2017-10-05 Normal 180 Day Track No User Fee
S008 2016-10-04 30-day Notice
S007 2016-09-21 30-day Notice
S006 2016-07-28 Normal 180 Day Track No User Fee
S005 2016-04-15 30-day Notice
S004 2016-04-15 30-day Notice
S003 2016-03-28 135 Review Track For 30-day Notice
S002 2015-11-04 Normal 180 Day Track No User Fee
S001 2015-07-24 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00850034511931 P120011 000
00850034511337 P120011 000
00850034511399 P120011 000
00850034511627 P120011 000
00850034511658 P120011 000
00850034511672 P120011 000
00850034511757 P120011 000
00850034511771 P120011 000
00850034511801 P120011 000
00850034511825 P120011 000
00850034511863 P120011 000
00850034511894 P120011 000
00850034511924 P120011 000
00850034511153 P120011 000

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