|
Device | REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER |
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 | S009 |
Date Received | 05/07/2010 |
Decision Date | 06/04/2010 |
Withdrawal Date
|
03/17/2017 |
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 MINOR CHANGES TO THE LABELING. |