|
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 | S032 |
Date Received | 10/06/2014 |
Decision Date | 11/05/2014 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING MODIFICATIONS TO 1) ADD IDENTIFIERS TO A PICTURE OF ACALIBRATION TUBE; AND (2) ADD A NOTE THAT THE USER SHOULD NOT OVERINFLATE THE BALLOON. |