PMA P160001S041

Device: Obalon Balloon Kit, Obalon Navigation Balloon Kit, and Obalon Touch Balloon Kit
Applicant: Medtimo, Inc.
PMA number: P160001
Supplement: S041
Product code: LTI
Decision date: 2019-07-03
Classification: Implant, Intragastric For Morbid Obesity
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: Change a manufacturing fixture component and tighten a process set-up acceptance criterion relating to balloon welding.

Current openFDA PMA Record#

Device: Obalon Balloon Kit, Obalon Navigation Balloon Kit, and Obalon Touch Balloon Kit
Applicant: Medtimo, Inc.
PMA number: P160001
Supplement: S041
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2019-07-03
Decision code: OK30
Date received: 2019-06-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change a manufacturing fixture component and tighten a process set-up acceptance criterion relating to balloon welding.