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 to allow for the routine parametric release of terminally moist-heat sterilized solutions by the ocntrol of process parameters for dextrose hm 32%
| Device | DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM |
| Classification Name | Fluid, Hysteroscopy |
| Generic Name | Fluid, Hysteroscopy |
| Applicant | Hospira, Inc. |
| Date Received | 1996-04-02 |
| Decision Date | 1996-09-05 |
| PMA | P880028 |
| Supplement | S007 |
| 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 |