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 for a change in the approved marketed product stability protocol for the dextran hm 32% to delete 3 and 6 month test stations from the approved stability protocol.
| Device | DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM |
| Classification Name | Fluid, Hysteroscopy |
| Generic Name | Fluid, Hysteroscopy |
| Applicant | Hospira, Inc. |
| Date Received | 1998-07-21 |
| Decision Date | 1999-01-29 |
| PMA | P880028 |
| Supplement | S008 |
| Product Code | LTA |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Hospira, Inc. 275 North Field Dr. dept. 389, Bldg. H2-2 lake Forest, IL 60045 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880028 | Original Filing | |
| S008 | 1998-07-21 | Normal 180 Day Track |
| S007 | 1996-04-02 | Normal 180 Day Track |
| S006 | 1995-11-17 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | 1995-06-19 | Normal 180 Day Track |
| S002 | 1990-07-12 | Normal 180 Day Track |
| S001 | 1989-07-24 | Normal 180 Day Track |