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 of a protocol for a postapproval study to examine the effects of the mentrual cycle on the results of the device.
| Device | TRANSCAN T-SCAN 2000 |
| Classification Name | Imager, Breast, Electrical Impedance |
| Generic Name | Imager, Breast, Electrical Impedance |
| Applicant | MIRABEL MEDICAL SYSTEMS, INC. |
| Date Received | 1999-06-15 |
| Decision Date | 2000-05-03 |
| PMA | P970033 |
| Supplement | S002 |
| Product Code | NCL |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MIRABEL MEDICAL SYSTEMS, INC. 9020 North Capitol Of Texas Highway suite 250 austin, TX 78759 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970033 | Original Filing | |
| S002 | 1999-06-15 | Normal 180 Day Track |
| S001 | 1999-06-23 | Normal 180 Day Track |