DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
FDA premarket approval P880028/S008 · decided 1999-01-29
Approval details
- PMA number
- P880028
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
- Generic name
- FLUID, HYSTEROSCOPY
- Applicant
- Hospira, Inc.
- Date received
- 1998-07-21
- Decision date
- 1999-01-29
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- LTA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Lake Forest, IL
- Statement
- 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.
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| Hospira Primary Sets (K143015) | Hospira, Inc. | 2015-02-25 |
| PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE (K141789) | Hospira, Inc. | 2015-01-16 |