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.
| Device | TROPHOCAN TM |
| Generic Name | Catheter, Sampling, Chorionic Villus |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
| Date Received | 1990-08-14 |
| Decision Date | 1990-08-17 |
| PMA | P890024 |
| Supplement | S001 |
| Product Code | LLX |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 Kit St. keene, NH 03431 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890024 | Original Filing | |
| S005 | 1992-05-04 | Normal 180 Day Track |
| S004 | 1991-05-30 | Special (immediate Track) |
| S003 | 1991-05-28 | Normal 180 Day Track |
| S002 | 1990-08-28 | Normal 180 Day Track |
| S001 | 1990-08-14 | Normal 180 Day Track |