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 HYSTEROSCOPY FLUID |
Generic Name | FLUID, HYSTEROSCOPY |
Applicant | COOPERVISION SURGICAL 95 Corporate Dr. Trumbull, CT 06611 |
PMA Number | N17511 |
Supplement Number | S013 |
Date Received | 01/10/2000 |
Decision Date | 02/09/2000 |
Withdrawal Date
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04/14/2009 |
Product Code |
LTA |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-day notice reqeusted the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility for the device. |
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