PMA P160001S040

Device: Obalon Touch Dispenser
Applicant: Medtimo, Inc.
PMA number: P160001
Supplement: S040
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 high pressure regulator and low pressure regulator target setpoints, the final release testing acceptance criteria for the regulator pressures, and the associated in-process and final acceptance activities.

Current openFDA PMA Record#

Device: Obalon Touch Dispenser
Applicant: Medtimo, Inc.
PMA number: P160001
Supplement: S040
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 high pressure regulator and low pressure regulator target setpoints, the final release testing acceptance criteria for the regulator pressures, and the associated in-process and final acceptance activities.