PMA supplement
P000040 S004: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Axora Medical, Inc.
Key facts
| Original PMA | P000040 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | Axora Medical, Inc. |
| Product code | MNB |
| Received date | Aug 25, 2003 |
| Decision date | Feb 24, 2004 |
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: