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 alternate manufacturing facility with roqueete america, inc. In keokuk, iowa, for dextrose usp. Hydrous bulk drug as a component of dextrose hm 32%
| Device | DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM |
| Classification Name | Fluid, Hysteroscopy |
| Generic Name | Fluid, Hysteroscopy |
| Applicant | Hospira, Inc. |
| Date Received | 1995-11-17 |
| Decision Date | 1996-01-04 |
| PMA | P880028 |
| Supplement | S006 |
| Product Code | LTA |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location 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 |