|
Device | RESHAPE INTEGRATED DUAL BALLOON SYSTEM |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P140012 |
Supplement Number | S005 |
Date Received | 09/26/2016 |
Decision Date | 10/25/2016 |
Withdrawal Date
|
07/23/2019 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of an inspection step (spin test) during commercial manufacturing and quality control activities. |