|
Device | Orbera Intragastric Balloon |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P140008 |
Supplement Number | S007 |
Date Received | 05/25/2017 |
Decision Date | 08/21/2017 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revised protocol for the post-approval study (PAS) protocol. |