HYSKON (32% DEXTRAN 70)

FDA Premarket Approval N17511 S002

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.

Pre-market Approval Supplement Details

DeviceHYSKON (32% DEXTRAN 70)
Generic NameFluid, Hysteroscopy
ApplicantCOOPERVISION SURGICAL
Date Received1982-08-18
Decision Date1982-10-14
PMAN17511
SupplementS002
Product CodeLTA 
Advisory CommitteeObstetrics/Gynecology
Expedited ReviewNo
Combination Product No
Applicant Address COOPERVISION SURGICAL 95 Corporate Dr. trumbull, CT 06611

Supplemental Filings

Supplement NumberDateSupplement Type
N17511Original Filing
S015 2008-04-08 30-day Notice
S014 2001-03-19 135 Review Track For 30-day Notice
S013 2000-01-10 30-day Notice
S012 1997-12-01 Normal 180 Day Track
S011 1994-11-10 Normal 180 Day Track
S010 1993-11-09 Normal 180 Day Track
S009 1991-04-30 Normal 180 Day Track
S008 1986-02-03
S007
S006 1985-01-11
S005 1984-03-30
S004 1984-03-30
S003 1982-09-10
S002 1982-08-18
S001 1981-04-22

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