PMA
P160047: MARA™ Vapor System, MARA™ Vapor Probe Procedure Kit, MARA™ Vapor Generator and MARA™ Vapor Generator Accessory Kit
FDA PMA · Device, thermal ablation, endometrial · CooperSurgical, Inc.
Key facts
| PMA number | P160047 |
|---|---|
| Trade name | MARA™ Vapor System, MARA™ Vapor Probe Procedure Kit, MARA™ Vapor Generator and MARA™ Vapor Generator Accessory Kit |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | CooperSurgical, Inc. |
| Owner/operator | COOPERSURGICAL, INC. |
| Product code | MNB |
| Approval date | Jun 14, 2017 |
| Docket number | 17M-3778 |
| Notice date | Jun 20, 2017 |
| Establishment registration | 1216677 |
| FEI number | 1216677 |
At a glance
- 10–99 Supplements
- Jan 7, 2025 Latest supplement decision
- No Withdrawn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: