|
Device | ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | OBTECH MEDICAL GMBH LANDIS AND GYR STRASSE 1 ZUG CH-63-6300 |
PMA Number | P070009 |
Supplement Number | S017 |
Date Received | 06/21/2016 |
Decision Date | 10/11/2016 |
Withdrawal Date
|
03/17/2017 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the device labeling made as a result of the approval of the 5 year Post-Approval Study. |