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. |
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Device | DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM |
Generic Name | FLUID, HYSTEROSCOPY |
Applicant | Hospira, Inc. 275 NORTH FIELD DR. DEPT. 389, BLDG. H2-2 LAKE FOREST, IL 60045 |
PMA Number | P880028 |
Supplement Number | S006 |
Date Received | 11/17/1995 |
Decision Date | 01/04/1996 |
Withdrawal Date
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12/19/2007 |
Product Code |
LTA |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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% |
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