PMA
P140012: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
FDA PMA · IMPLANT, INTRAGASTRIC FOR MORBID OBESITY · Boston Scientific Corporation
Key facts
| PMA number | P140012 |
|---|---|
| Trade name | RESHAPE INTEGRATED DUAL BALLOON SYSTEM |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Boston Scientific Corporation |
| Owner/operator | FlowPhysix, Inc. |
| Product code | LTI |
| Approval date | Jul 28, 2015 |
| Docket number | 15M-2740 |
| Notice date | Jul 29, 2015 |
| Establishment registration | 3040099838 |
| FEI number | 3040099838 |
At a glance
- 10–99 Supplements
- May 31, 2018 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: