PMA supplement
P040005 S003: HER2FISH PHARMDX KIT
FDA PMA supplement · Real-Time Process · Agilent Technologies Singapore (International) Pte, Ltd.
Key facts
| Original PMA | P040005 |
|---|---|
| Supplement number | S003 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | HER2FISH PHARMDX KIT |
| Generic name | System, Test, Her-2/Neu, Nucleic Acid Or Serum |
| Applicant | Agilent Technologies Singapore (International) Pte , Ltd. |
| Product code | MVD |
| Received date | Jul 10, 2008 |
| Decision date | Oct 10, 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: