PMA supplement
P920048 S002: ADEZA FETAL FIBRONECTIN EIK
FDA PMA supplement · Normal 180 Day Track · Hologic, Inc.
Key facts
| Original PMA | P920048 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ADEZA FETAL FIBRONECTIN EIK |
| Generic name | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN |
| Applicant | Hologic, Inc. |
| Product code | LKV |
| Received date | Feb 13, 1998 |
| Decision date | Aug 14, 1998 |
At a glance
- Yes 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: