|
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 | S038 |
Date Received | 02/15/2017 |
Decision Date | 03/23/2017 |
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 Removal of the Ultrasonic Thickness Gauge (UTG) inspection step of the “shell” thickness of the band of the LAP-BAND Adjustable Gastric Banding System from the incoming product inspection protocol. |