ORBERA® Intragastric Balloon (IGB) System

FDA Premarket Approval P140008 S023

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

Manufacturing changes to the sheath assembly procedures.

DeviceORBERA® Intragastric Balloon (IGB) System
Generic NameImplant, Intragastric For Morbid Obesity
ApplicantAPOLLO ENDOSURGERY INC
Date Received2021-12-06
Decision Date2021-12-21
PMAP140008
SupplementS023
Product CodeLTI 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-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
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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