PMA supplement
P980018 S010: HERCEPTEST
FDA PMA supplement · Panel Track · Agilent Technologies Singapore (International) Pte, Ltd.
Key facts
| Original PMA | P980018 |
|---|---|
| Supplement number | S010 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | HERCEPTEST |
| Generic name | SYSTEM, TEST, HER-2/NEU, IHC |
| Applicant | Agilent Technologies Singapore (International) Pte , Ltd. |
| Product code | MVC |
| Received date | Apr 21, 2010 |
| Decision date | Oct 20, 2010 |
| Docket number | 10M-0557 |
| Notice date | Nov 17, 2010 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: