|
Device | ReShape Lap-Band System |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92672 |
PMA Number | P000008 |
Supplement Number | S049 |
Date Received | 01/23/2024 |
Decision Date | 01/26/2024 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval to change the product trade name from “Lap-Band Adjustable Gastric Banding System” to “ReShape Lap-Band Adjustable Gastric Banding System” |