DEXON

FDA Premarket Approval N16881 S010

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

DeviceDEXON
Generic NameSuture, Absorbable, Synthetic, Polyglycolic Acid
ApplicantDAVIS & GECK, INC.
Date Received1987-04-14
Decision Date1987-06-05
PMAN16881
SupplementS010
Product CodeGAM 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DAVIS & GECK, INC. american Cynamid Company one Casper Street danbury, CT 06810

Supplemental Filings

Supplement NumberDateSupplement Type
N16881Original Filing
S011 1987-10-14 Normal 180 Day Track
S010 1987-04-14 Normal 180 Day Track
S009 1986-10-28 Normal 180 Day Track
S008 1986-03-25
S007
S006 1981-07-01
S005 1981-06-04
S004 1981-05-19
S003 1980-08-29
S002 1980-11-17
S001 1980-10-22

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