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.
The 30-day notice reqeusted the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility for the device.
| Device | HYSKON HYSTEROSCOPY FLUID |
| Generic Name | Fluid, Hysteroscopy |
| Applicant | COOPERVISION SURGICAL |
| Date Received | 2000-01-10 |
| Decision Date | 2000-02-09 |
| PMA | N17511 |
| Supplement | S013 |
| Product Code | LTA |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOPERVISION SURGICAL 95 Corporate Dr. trumbull, CT 06611 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17511 | Original Filing | |
| S015 | 2008-04-08 | 30-day Notice |
| S014 | 2001-03-19 | 135 Review Track For 30-day Notice |
| S013 | 2000-01-10 | 30-day Notice |
| S012 | 1997-12-01 | Normal 180 Day Track |
| S011 | 1994-11-10 | Normal 180 Day Track |
| S010 | 1993-11-09 | Normal 180 Day Track |
| S009 | 1991-04-30 | Normal 180 Day Track |
| S008 | 1986-02-03 | |
| S007 | ||
| S006 | 1985-01-11 | |
| S005 | 1984-03-30 | |
| S004 | 1984-03-30 | |
| S003 | 1982-09-10 | |
| S002 | 1982-08-18 | |
| S001 | 1981-04-22 |