IDEAL IMPLANT Structured Breast Implant

FDA Premarket Approval P120011 S022

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.

DeviceIDEAL IMPLANT Structured Breast Implant
Generic NameProsthesis, Breast, Inflatable, Internal, Saline
ApplicantIDEALIMPLANT
Date Received2021-05-27
Decision Date2021-10-27
PMAP120011
SupplementS022
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address IDEALIMPLANT 14881 Quorum Drive Suite 925 dallas, TX 75254
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P120011Original Filing
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

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