This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changes in the product insert: 1) manufacturing address change; 2) copyright change from invitrogen corporation to life technologies. Invitrogen will remain the brand name and therefore is still included on the product insert and labeling; and an addition of literature references to the bibliography.
| Device | SPOT-LIGHT HER2 CISH KIT |
| Generic Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Applicant | INVITROGEN CORPORATION |
| Date Received | 2011-03-01 |
| Decision Date | 2011-04-29 |
| PMA | P050040 |
| Supplement | S002 |
| Product Code | NYQ |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INVITROGEN CORPORATION 3175 Staley Rd. grand Island, NY 14072 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050040 | Original Filing | |
| S003 | 2012-06-01 | 30-day Notice |
| S002 | 2011-03-01 | Real-time Process |
| S001 | 2011-02-03 | Normal 180 Day Track No User Fee |