PMA supplement
P000040 S035: Genesys Hta 115V Control Unit, Genesys Hta 115V Control Unit (Demo), Genesys Hta 115V Control Unit (Refurb), Genesys Hta
FDA PMA supplement · Normal 180 Day Track No User Fee · Axora Medical, Inc.
Key facts
| Original PMA | P000040 |
|---|---|
| Supplement number | S035 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Genesys Hta 115V Control Unit, Genesys Hta 115V Control Unit (Demo), Genesys Hta 115V Control Unit (Refurb), Genesys Hta |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | Axora Medical, Inc. |
| Product code | MNB |
| Received date | Apr 11, 2017 |
| Decision date | Jun 29, 2017 |
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: