PMA P880028S007

Device: DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Applicant: Hospira, Inc.
PMA number: P880028
Supplement: S007
Product code: LTA
Decision date: 1996-09-05
Classification: Fluid, Hysteroscopy
Generic name: FLUID, HYSTEROSCOPY
Approval order statement: APPROVAL TO ALLOW FOR THE ROUTINE PARAMETRIC RELEASE OF TERMINALLY MOIST-HEAT STERILIZED SOLUTIONS BY THE OCNTROL OF PROCESS PARAMETERS FOR DEXTROSE HM 32%

Current openFDA PMA Record#

Device: DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Applicant: Hospira, Inc.
PMA number: P880028
Supplement: S007
Product code: LTA
Generic name: FLUID, HYSTEROSCOPY
Decision date: 1996-09-05
Decision code: APPR
Date received: 1996-04-02
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO ALLOW FOR THE ROUTINE PARAMETRIC RELEASE OF TERMINALLY MOIST-HEAT STERILIZED SOLUTIONS BY THE OCNTROL OF PROCESS PARAMETERS FOR DEXTROSE HM 32%