|
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 | S022 |
Date Received | 05/19/2021 |
Decision Date | 08/12/2021 |
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 change in the material used to manufacture the fill tube component. |