PMA
P970058: M1000 IMAGECHECKER
FDA PMA · Analyzer, medical image · Hologic, Inc.
Key facts
| PMA number | P970058 |
|---|---|
| Trade name | M1000 IMAGECHECKER |
| Generic name | Analyzer, medical image |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | MYN |
| Approval date | Jun 26, 1998 |
| Docket number | 98M-0618 |
| Notice date | Aug 12, 1998 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- 10–99 Supplements
- Apr 26, 2016 Latest supplement decision
- No Withdrawn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: