PMA supplement
P120007 S001: APTIMA HPV 16 18/45 GENOTYPE ASSAY
FDA PMA supplement · Normal 180 Day Track · Gen-Probe Incorporated
Key facts
| Original PMA | P120007 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | APTIMA HPV 16 18/45 GENOTYPE ASSAY |
| Generic name | Kit, rna detection, human papillomavirus |
| Applicant | Gen-Probe Incorporated |
| Product code | OYB |
| Received date | May 15, 2013 |
| Decision date | Nov 6, 2013 |
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: