This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | COOK CHORIONIC VILLUS SAMPLING SET |
| Generic Name | Catheter, Sampling, Chorionic Villus |
| Applicant | Cook Incorporated |
| Date Received | 1990-02-01 |
| Decision Date | 1994-09-30 |
| Notice Date | 1994-11-14 |
| PMA | P900007 |
| Supplement | S |
| Product Code | LLX |
| Docket Number | 94M-0364 |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cook Incorporated 750 Daniels Way p.o. Box 489 bloomington, IN 47402 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900007 | Original Filing | |
| S006 | 2008-12-02 | 30-day Notice |
| S005 | 2008-11-17 | Real-time Process |
| S004 | 2008-04-01 | 30-day Notice |
| S003 | ||
| S002 | 2000-01-04 | Normal 180 Day Track |
| S001 | 1998-01-15 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00827002169081 | P900007 | 001 |
| 00827002190276 | P900007 | 002 |