PMA
P970021: THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
FDA PMA · Device, thermal ablation, endometrial · Gynecare, Inc.
Key facts
| PMA number | P970021 |
|---|---|
| Trade name | THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | Gynecare, Inc. |
| Product code | MNB |
| Approval date | Dec 12, 1997 |
| Docket number | 98M-0139 |
| Notice date | Mar 4, 1998 |
| FEI number | 3000206804 |
At a glance
- 10–99 Supplements
- Jan 4, 2016 Latest supplement decision
- Yes Withdrawn
- No 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: