PMA supplement
P040052 S005: MONOPREP PAP TEST
FDA PMA supplement · Normal 180 Day Track No User Fee · Hologic, Inc.
Key facts
| Original PMA | P040052 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Express GMP Supplement |
| Trade name | MONOPREP PAP TEST |
| Generic name | Processor, cervical cytology slide, automated |
| Applicant | Hologic, Inc. |
| Product code | MKQ |
| Received date | Oct 22, 2007 |
| Decision date | Aug 11, 2008 |
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: