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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceHYSKON (32% DEXTRAN 70)
Generic NameFLUID, HYSTEROSCOPY
ApplicantCoopervision Surgical
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberN17511
Supplement NumberS012
Date Received12/01/1997
Decision Date12/30/1997
Withdrawal Date04/14/2009
Product Code LTA 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing facility located at NPBI, Nederlands Produktielaboratorium Voor, Bloedtransfusieapparatuur en Infusievloeistoffen B.V., Runde ZZ 41, 7881 HM Emmer-Compascuum, The Netherlands.
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