|
Device | Obalon Balloon System with Navigation and Touch |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92673 |
PMA Number | P160001 |
Supplement Number | S032 |
Date Received | 01/31/2019 |
Decision Date | 03/01/2019 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of a cybersecurity update for a manufacturing process. |