DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

Fluid, Hysteroscopy

FDA Premarket Approval P880028 S008

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.

Pre-market Approval Supplement Details

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.

DeviceDEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Classification NameFluid, Hysteroscopy
Generic NameFluid, Hysteroscopy
ApplicantHospira, Inc.
Date Received1998-07-21
Decision Date1999-01-29
PMAP880028
SupplementS008
Product CodeLTA
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Hospira, Inc. 275 North Field Dr. dept. 389, Bldg. H2-2 lake Forest, IL 60045

Supplemental Filings

Supplement NumberDateSupplement Type
P880028Original 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

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