Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceDEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Generic NameFLUID, HYSTEROSCOPY
ApplicantHospira, Inc.
275 NORTH FIELD DR.
DEPT. 389, BLDG. H2-2
LAKE FOREST, IL 60045
PMA NumberP880028
Supplement NumberS003
Date Received06/19/1995
Decision Date12/15/1995
Withdrawal Date 12/19/2007
Product Code LTA 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DELETING THE TEST FOR ANTIGENIC IMPURITIES IN THE TESTING SPECIFICATIONS FOR THE DEXTRAN 70 (CODE 59479) BULK DRUG SUBSTANCE
-
-