PMA supplement
P050040 S003: SPOT-LIGHT HER2 CISH KIT
FDA PMA supplement · 30-Day Notice · Invitrogen Corporation
Key facts
| Original PMA | P050040 |
|---|---|
| Supplement number | S003 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | SPOT-LIGHT HER2 CISH KIT |
| Generic name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Applicant | Invitrogen Corporation |
| Product code | NYQ |
| Received date | Jun 1, 2012 |
| Decision date | Jul 6, 2012 |
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: