PMA P880028

Device: DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Applicant: Hospira, Inc.
PMA number: P880028
Supplement: S008
Product code: LTA
Decision date: 1999-01-29
Classification: Fluid, Hysteroscopy
Generic name: FLUID, HYSTEROSCOPY
Approval order 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.

Current openFDA PMA Record#

Device: DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Applicant: Hospira, Inc.
PMA number: P880028
Supplement: S008
Product code: LTA
Generic name: FLUID, HYSTEROSCOPY
Decision date: 1999-01-29
Decision code: APPR
Date received: 1998-07-21
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.