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 | HYSKON (32% DEXTRAN 70) |
Generic Name | FLUID, HYSTEROSCOPY |
Applicant | COOPERVISION SURGICAL 95 Corporate Dr. Trumbull, CT 06611 |
PMA Number | N17511 |
Supplement Number | S011 |
Date Received | 11/10/1994 |
Decision Date | 07/18/1995 |
Withdrawal Date
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04/14/2009 |
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 THE USE OF A LAGARDE STERILIZER, 551015, IN YOUR CLAYTON, N.C. FACILITY TO TERMINALLY STERILIZE HYSKON HYSTEROSCOPY FLUID, 32% (DEXTRAN 70) IN 100 ML TO 250 ML GLASS BOTTLE:TRANSFER OF OWNERSHIP TO MADISAN PHARMACEUTICALS, INC. |
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