|
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 | S017 |
Date Received | 03/04/2019 |
Decision Date | 06/03/2019 |
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 revised labeling to include current post-market surveillance information, clarifications intended to enhance safety, and additional labeling pieces intended to enhance safety. |