|
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 | S003 |
Date Received | 09/18/2015 |
Decision Date | 05/23/2016 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a manufacturing site located at Apollo Endosurgery, Building 13.3, Zona Franca Coyol, Alajuela, Costa Rica |