|
Device | Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band |
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 | S016 |
Date Received | 04/21/2016 |
Decision Date | 05/16/2016 |
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 - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the trade name changes from REALIZE Adjustable Gastric Band-C with Injection Port and Applier to Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier, and REALIZE Injection Port and Applier to Ethicon Endo-Surgery Gastric Band Sutureless Port and Applier. |