|
Device | Orbera Intragastric Balloon System |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P140008 |
Supplement Number | S006 |
Date Received | 05/08/2017 |
Decision Date | 06/06/2017 |
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 labeling changes have been requested by the Office of Surveillance and Biometrics, Signal Management Program as a result of a safety signal with fluid filled gastric balloons. |