GORE-TEX(R) EXPANDED PTFE SUTURE

FDA Premarket Approval P820083 S012

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

DeviceGORE-TEX(R) EXPANDED PTFE SUTURE
Generic NameSuture, Nonabsorbable, Synthetic, Polypropylene
ApplicantW.L. GORE & ASSOCIATES,INC
Date Received1990-08-17
Decision Date1990-10-19
PMAP820083
SupplementS012
Product CodeGAW 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address W.L. GORE & ASSOCIATES,INC 1500 N. Fourth St. p.o. Box 3000 flagstaff, AZ 86003

Supplemental Filings

Supplement NumberDateSupplement Type
P820083Original Filing
S025 1998-07-23 Real-time Process
S024 1996-09-18 Real-time Process
S023 1996-09-16 Real-time Process
S022 1996-09-03 Real-time Process
S021 1996-09-03 Real-time Process
S020 1995-01-30 Normal 180 Day Track
S019 1994-05-23 Normal 180 Day Track
S018 1994-03-18 Normal 180 Day Track
S017 1994-01-05 Normal 180 Day Track
S016 1993-11-04 Normal 180 Day Track
S015 1993-09-22 Normal 180 Day Track
S014 1992-09-08 Normal 180 Day Track
S013 1991-11-27 Normal 180 Day Track
S012 1990-08-17 Normal 180 Day Track
S011
S010 1989-05-08 Normal 180 Day Track
S009 1988-11-18 Special (immediate Track)
S008 1988-10-18 Normal 180 Day Track
S007 1988-09-26 Normal 180 Day Track
S006 1987-09-18 Normal 180 Day Track
S005 1987-05-26 Normal 180 Day Track
S004 1986-06-12 Normal 180 Day Track
S003 1986-05-23
S002 1986-05-02
S001 1986-04-08

NIH GUDID Devices

Device IDPMASupp
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