SURGILENE

FDA Premarket Approval N17825 S011

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

DeviceSURGILENE
Generic NameSuture, Nonabsorbable, Synthetic, Polyethylene
ApplicantDAVIS & GECK, INC.
Date Received1982-06-17
Decision Date1982-07-16
PMAN17825
SupplementS011
Product CodeGAT 
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address DAVIS & GECK, INC. american Cynamid Company one Casper Street danbury, CT 06810

Supplemental Filings

Supplement NumberDateSupplement Type
N17825Original Filing
S017 1988-05-03 Normal 180 Day Track
S016 1988-02-02 Special (immediate Track)
S015 1987-04-14 Normal 180 Day Track
S014 1985-07-02
S013 1984-02-06
S012 1981-07-08
S011 1982-06-17
S010 1982-06-17
S009 1981-07-06
S008 1980-12-01
S007
S006
S005
S004
S003
S002
S001 1980-11-24

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