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.
| Device | ORBERA ® Intragastric Balloon (IGB) System |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | APOLLO ENDOSURGERY INC1120 S Capital Of Tx Hwybldg 1, Ste 300austin, TX 78746-0000 PMA NumberP140008 Supplement NumberS024 Date Received07/11/2022 Decision Date10/05/2022 Product Code LTI Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-07-11 |
| Decision Date | 2022-10-05 |
| PMA | P140008 |
| Supplement | S024 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | APOLLO ENDOSURGERY INC 1120 S Capital Of Tx Hwy bldg 1, Ste 300 austin, TX 78746-0000 PMA NumberP140008 Supplement NumberS024 Date Received07/11/2022 Decision Date10/05/2022 Product Code LTI Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Continued Approval Of This PMA Is Contingent Upon The Submission Of Periodic Reports, Required Under 21 CFR 814.84, At Intervals Of One Year (unless Otherwise Specified) From The Date Of Approval Of The Original PMA. Two Copies Of This Report, Identified As "AnnualReport"and Bearing The Applicable PMA Reference Number, Should Be Submitted To The Address Below. The Annual Report Should Indicate The Beginning And Ending Date Of The Period Covered By The Report And Should Include The Information Required By 21 CFR 814.84. This Is A Reminder That As Of September 24, 2014, Class III Devices Are Subject To Certain Provisions Of The Final UDI Rule. These Provisions Include The Requirement To Provide A UDI On The Device Label And Packages (21 CFR 801.20), Format Dates On The Device Label In Accordance With 21 CFR 801.18, And Submit Data To The Global Unique Device Identification Database (GUDID) (21 CFR 830 Subpart E). Additionally, 21 CFR 814.84 (b)(4) Requires PMA Annual Reports Submitted After September 24, 2014, To Identify Each Device Identifier Currently In Use For The Subject Device, And The Device Identifiers For Devices That Have Been Discontinued Since The Previous Periodic Report. It Isnot Necessary To Identify Any Device Identifier Discontinued Prior To December 23, 2013. For More Information On These Requirements, Please See The UDI Website, Http://www.fda.gov/udi |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140008 | Original Filing | |
| S024 | 2022-07-11 | Real-time Process |
| S023 | 2021-12-06 | 30-day Notice |
| S022 | 2021-05-19 | Real-time Process |
| S021 | 2020-09-18 | Special (immediate Track) |
| S020 | ||
| S019 | ||
| S018 | 2019-06-24 | 30-day Notice |
| S017 | 2019-03-04 | Special (immediate Track) |
| S016 | ||
| S015 | ||
| S014 | 2018-10-02 | Normal 180 Day Track No User Fee |
| S013 | 2018-06-12 | Normal 180 Day Track No User Fee |
| S012 | 2018-05-01 | Special (immediate Track) |
| S011 | 2017-12-27 | Special (immediate Track) |
| S010 | ||
| S009 | ||
| S008 | 2017-11-06 | 135 Review Track For 30-day Notice |
| S007 | 2017-05-25 | Normal 180 Day Track No User Fee |
| S006 | 2017-05-08 | Special (immediate Track) |
| S005 | 2017-04-12 | 30-day Notice |
| S004 | ||
| S003 | 2015-09-18 | Normal 180 Day Track No User Fee |
| S002 | 2015-09-03 | Normal 180 Day Track No User Fee |
| S001 | 2015-08-31 | 135 Review Track For 30-day Notice |