PMA
P000032: HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
FDA PMA · Device, thermal ablation, endometrial · CooperSurgical, Inc.
Key facts
| PMA number | P000032 |
|---|---|
| Trade name | HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM |
| Generic name | Device, thermal ablation, endometrial |
| Applicant | CooperSurgical, Inc. |
| Owner/operator | COOPERSURGICAL, INC. |
| Product code | MNB |
| Approval date | Apr 20, 2001 |
| Docket number | 01M-0412 |
| Notice date | Sep 24, 2001 |
| Establishment registration | 1216677 |
| FEI number | 1216677 |
At a glance
- 10–99 Supplements
- Jul 11, 2018 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- No Withdrawn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: