SUPRAMID EXTRA SUTURES

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Premarket Approval N80838 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

DeviceSUPRAMID EXTRA SUTURES
Classification NameSuture, Nonabsorbable, Synthetic, Polyamide
Generic NameSuture, Nonabsorbable, Synthetic, Polyamide
ApplicantS. Jackson, Inc.
Date Received1987-02-11
Decision Date1987-06-29
PMAN80838
SupplementS011
Product CodeGAR
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
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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