|
Device | REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C |
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 | S008 |
Date Received | 06/07/2010 |
Decision Date | 07/30/2010 |
Withdrawal Date
|
03/17/2017 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DEVICE CHANGE TO ADD A SILICONE ADHESIVE TO BOND THE STRAIN RELIEF SLEEVE AND THE LOCKING CONNECTOR COMPONENTS OF THE INJECTION PORT. |