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 | S008 |
Date Received | 07/21/1998 |
Decision Date | 01/29/1999 |
Withdrawal Date
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12/19/2007 |
Product Code |
LTA |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
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