PMA supplement
P140012 S012: ReShape Integrated Dual Balloon System
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Corporation
Key facts
| Original PMA | P140012 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| Trade name | ReShape Integrated Dual Balloon System |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Boston Scientific Corporation |
| Product code | LTI |
| Received date | Feb 26, 2018 |
| Decision date | May 30, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: