|
Device | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92672 |
PMA Number | P000008 |
Supplement Number | S034 |
Date Received | 07/06/2015 |
Decision Date | 03/03/2016 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the following changes to the post-approval study for the device: revisions reflecting alignment of protocol terminology with terms used in the electronic datamanagement system and points of clarification based on IRB input. |