RESHAPE INTEGRATED DUAL BALLOON SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Premarket Approval P140012 S005

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

Addition of an inspection step (spin test) during commercial manufacturing and quality control activities.

• Device: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Classification Name: Implant, Intragastric For Morbid Obesity
• Generic Name: Implant, Intragastric For Morbid Obesity
• Applicant: Appollo Endosurgery
• Date Received: 2016-09-26
• Decision Date: 2016-10-25
• PMA: P140012
• Supplement: S005
• Product Code: LTI
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Appollo Endosurgery 1120 S Capital Of Tx Hwy bldg 1, Ste 300 austin, TX 78746

Supplemental Filings

Supplement Number	Date	Supplement Type
P140012		Original Filing
S013	2018-05-02	Special (immediate Track)
S012	2018-02-26	Normal 180 Day Track No User Fee
S011	2017-09-27	30-day Notice
S010	2017-04-28	Normal 180 Day Track No User Fee
S009	2017-03-22	Special (immediate Track)
S008	2017-01-23	30-day Notice
S007	2016-12-19	30-day Notice
S006	2016-12-07	30-day Notice
S005	2016-09-26	30-day Notice
S004	2015-12-01	30-day Notice
S003	2015-11-18	Real-time Process
S002	2015-09-28	Normal 180 Day Track
S001	2015-08-26	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
B001RSM9001	P140012	000
B001RSM2101	P140012	000
B001RSM1011	P140012	000
B001RSM1101	P140012	002