|
Device | REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND 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 | S010 |
Date Received | 06/29/2010 |
Decision Date | 07/26/2010 |
Withdrawal Date
|
03/17/2017 |
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 ADDITION OF AN ALTERNATE SUB-ASSEMBLY SUPPLIER. |