PMA P880028S006

Device: DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Applicant: Hospira, Inc.
PMA number: P880028
Supplement: S006
Product code: LTA
Decision date: 1996-01-04
Classification: Fluid, Hysteroscopy
Generic name: FLUID, HYSTEROSCOPY
Approval order statement: 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%

Current openFDA PMA Record#

Device: DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Applicant: Hospira, Inc.
PMA number: P880028
Supplement: S006
Product code: LTA
Generic name: FLUID, HYSTEROSCOPY
Decision date: 1996-01-04
Decision code: APPR
Date received: 1995-11-17
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 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%