|
Device | Obalon Ballon 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 | S044 |
Date Received | 11/13/2019 |
Decision Date | 02/11/2020 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modification to the software of the Obalon Navigation Console. |