PMA supplement
P160047 S007: Mara Water Vapor Ablation System, Mara Water Vapor Probe Procedure Kit, Mara Water Vapor Probe, Mara Supply and Drain Ac
FDA PMA supplement · Normal 180 Day Track No User Fee · CooperSurgical, Inc.
Key facts
| Original PMA | P160047 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Mara Water Vapor Ablation System, Mara Water Vapor Probe Procedure Kit, Mara Water Vapor Probe, Mara Supply and Drain Ac |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | CooperSurgical, Inc. |
| Product code | MNB |
| Received date | Oct 10, 2019 |
| Decision date | Nov 4, 2019 |
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: