PMA
P970032: SALEST TM SYSTEM
FDA PMA · Salivary estriol test · Hologic, Inc.
Key facts
| PMA number | P970032 |
|---|---|
| Trade name | SALEST TM SYSTEM |
| Generic name | Salivary estriol test |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | PEJ |
| Approval date | Apr 29, 1998 |
| Docket number | 99M-2168 |
| Notice date | Jul 13, 1999 |
| Establishment registration | 3005496266 |
| FEI number | 3005496266 |
At a glance
- 1–9 Supplements
- Aug 26, 1999 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: