|
Device | ORBERA ® Intragastric Balloon (IGB) System |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P140008 |
Supplement Number | S024 |
Date Received | 07/11/2022 |
Decision Date | 10/05/2022 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the physician labeling to update Table 21: ORBERA device- and procedure- related adverse events and complaints reported through clinical product surveillance. |