SILK NONABSORBABLE SUTURES, USP

FDA Premarket Approval N84047 S014

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

DeviceSILK NONABSORBABLE SUTURES, USP
Generic NameSuture, Nonabsorbable, Silk
ApplicantDAVIS & GECK, INC.
Date Received1987-04-14
Decision Date1987-06-05
PMAN84047
SupplementS014
Product CodeGAP 
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
N84047Original Filing
S014 1987-04-14 Normal 180 Day Track
S013 1986-10-10 Normal 180 Day Track
S012 1986-09-30 Normal 180 Day Track
S011 1986-07-01 Normal 180 Day Track
S010 1986-04-29
S009
S008 1982-12-29
S007 1982-06-17
S006 1982-06-17
S005
S004 1981-12-15
S003
S002 1980-12-16
S001 1980-09-12

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