PMA P160001S002

Device: OBALON BALLOON SYSTEM
Applicant: Medtimo, Inc.
PMA number: P160001
Supplement: S002
Product code: LTI
Decision date: 2016-12-15
Classification: Implant, Intragastric For Morbid Obesity
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: Change manufacturing specifications to narrow the EzFill Dispenser set point to the nearest 10 feet in clinical site altitude across a range of +/-150 feet in dispenser altitude.

Current openFDA PMA Record#

Device: OBALON BALLOON SYSTEM
Applicant: Medtimo, Inc.
PMA number: P160001
Supplement: S002
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2016-12-15
Decision code: OK30
Date received: 2016-11-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change manufacturing specifications to narrow the EzFill Dispenser set point to the nearest 10 feet in clinical site altitude across a range of +/-150 feet in dispenser altitude.