PMA supplement
P140012 S003: RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT
FDA PMA supplement · Real-Time Process · Boston Scientific Corporation
Key facts
| Original PMA | P140012 |
|---|---|
| Supplement number | S003 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Boston Scientific Corporation |
| Product code | LTI |
| Received date | Nov 18, 2015 |
| Decision date | Jan 22, 2016 |
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: