SUPRAMID EXTRA SUTURES

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Premarket Approval N80838 S015

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

DeviceSUPRAMID EXTRA SUTURES
Classification NameSuture, Nonabsorbable, Synthetic, Polyamide
Generic NameSuture, Nonabsorbable, Synthetic, Polyamide
ApplicantS. Jackson, Inc.
Date Received1989-05-01
Decision Date1989-06-08
PMAN80838
SupplementS015
Product CodeGAR
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address S. Jackson, Inc. 15 Roth St. p.o. Box 4487 alexandria, VA 22303

Supplemental Filings

Supplement NumberDateSupplement Type
N80838Original Filing
S017 1989-12-21 Normal 180 Day Track
S016 1989-09-20 Normal 180 Day Track
S015 1989-05-01 Normal 180 Day Track
S014 1989-02-27 Normal 180 Day Track
S013 1988-06-22 Normal 180 Day Track
S012 1987-07-21 Normal 180 Day Track
S011 1987-02-11 Normal 180 Day Track
S010 1986-07-08 Normal 180 Day Track
S009 1985-06-05
S008 1985-03-27
S007 1984-11-13
S006 1984-03-07
S005
S004
S003
S002 1982-11-02
S001 1982-11-02

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