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.
Extension of the expiration date for a single lot of her-2 spt dna template (lot 63013).
| 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 | 2012-06-01 |
| Decision Date | 2012-07-06 |
| PMA | P050040 |
| Supplement | S003 |
| Product Code | NYQ |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |