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 deleting the test for antigenic impurities in the testing specifications for the dextran 70 (code 59479) bulk drug substance
| Device | DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM |
| Classification Name | Fluid, Hysteroscopy |
| Generic Name | Fluid, Hysteroscopy |
| Applicant | Hospira, Inc. |
| Date Received | 1995-06-19 |
| Decision Date | 1995-12-15 |
| PMA | P880028 |
| Supplement | S003 |
| Product Code | LTA |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |