ORBERA Intragastric Balloon System

Implant, Intragastric For Morbid Obesity

FDA Premarket Approval P140008 S008

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 increases to the routine bioburden monitoring alert and action limits.

DeviceORBERA Intragastric Balloon System
Classification NameImplant, Intragastric For Morbid Obesity
Generic NameImplant, Intragastric For Morbid Obesity
ApplicantAPOLLO ENDOSURGERY INC
Date Received2017-11-06
Decision Date2018-09-04
PMAP140008
SupplementS008
Product CodeLTI
Advisory CommitteeGastroenterology/Urology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address APOLLO ENDOSURGERY INC 1120 S Capital Of Tx Hwy bldg 1, Ste 300 austin, TX 78746-0000

Supplemental Filings

Supplement NumberDateSupplement Type
P140008Original 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

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