W L Gore Associates FDA Filings

Device Company	Device	Date
PMN K120480 W.L. GORE & ASSOCIATES	GORE(R) EMBOLIC FILTER	2012-03-16
PMN K093934 W.L. GORE & ASSOCIATES	GORE HYBRID VASCULAR GRAFT	2010-03-17
PMN K053202 W.L. GORE & ASSOCIATES	GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL	2005-12-07

Similar & Related FDA Registered Companies

W. L. GORE & ASSOCIATES, INC.
W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV.
W. L. GORE & ASSOCIATES, INC.3450 Kiltie Lanep.o. Box 2400flagstaff, AZ 86003-2400 PMA NumberP040043 Supplement NumberS132 Date Received12/15/2022 Decision Date01/12/2023 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS005 Date Received12/15/2022 Decision Date12/21/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS105 Date Received12/15/2022 Decision Date12/21/2022 Product Code MLV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS036 Date Received12/15/2022 Decision Date12/21/2022 Product Code PRL Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC3250 W.kiltie Laneflagstaff, AZ 86001 PMA NumberP130006 Supplement NumberS094 Date Received12/15/2022 Decision Date12/21/2022 Product Code PFV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC3450 West Kiltie Ln.p.o. Box 500flagstaff, AZ 86002-0500 PMA NumberP040037 Supplement NumberS155 Date Received12/15/2022 Decision Date12/21/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS104 Date Received11/18/2022 Decision Date12/15/2022 Product Code MLV Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP020004 Supplement NumberS193 Date Received10/21/2022 Decision Date11/18/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS004 Date Received09/06/2022 Decision Date10/05/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. GORE & ASSOCIATES, INC.3450 Kiltie Lanep.o. Box 2400flagstaff, AZ 86003-2400 PMA NumberP040043 Supplement NumberS131 Date Received09/06/2022 Decision Date10/05/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP020004 Supplement NumberS192 Date Received09/06/2022 Decision Date10/05/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore And Associates, Inc.32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP200030 Supplement NumberS010 Date Received09/06/2022 Decision Date10/05/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS102 Date Received09/09/2022 Decision Date09/23/2022 Product Code MLV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP020004 Supplement NumberS191 Date Received08/12/2022 Decision Date09/13/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC3450 West Kiltie Ln.p.o. Box 500flagstaff, AZ 86002-0500 PMA NumberP040037 Supplement NumberS154 Date Received08/08/2022 Decision Date09/01/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC3250 W.kiltie Laneflagstaff, AZ 86001 PMA NumberP130006 Supplement NumberS093 Date Received08/08/2022 Decision Date09/01/2022 Product Code PFV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP020004 Supplement NumberS190 Date Received08/01/2022 Decision Date08/31/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. GORE & ASSOCIATES, INC.32360 N North Valley Parkwayphoenix, AZ 85085 PMA NumberP040027 Supplement NumberS092 Date Received07/25/2022 Decision Date08/24/2022 Product Code MIR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore And Associates, Inc.32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP200030 Supplement NumberS009 Date Received08/03/2022 Decision Date08/16/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS003 Date Received07/26/2022 Decision Date08/05/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP020004 Supplement NumberS189 Date Received02/01/2022 Decision Date07/28/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
W. L. Gore And Associates, Inc.32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP200030 Supplement NumberS008 Date Received06/28/2022 Decision Date07/27/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS002 Date Received06/22/2022 Decision Date07/21/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS001 Date Received06/09/2022 Decision Date07/08/2022 Product Code MIH Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
W. L. GORE & ASSOCIATES, INC.32360 N North Valley Parkwayphoenix, AZ 85085 PMA NumberP040027 Supplement NumberS091 Date Received06/27/2022 Decision Date07/07/2022 Product Code MIR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS100 Date Received06/06/2022 Decision Date07/06/2022 Product Code MLV Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS035 Date Received06/08/2022 Decision Date07/05/2022 Product Code PRL Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Date Received08/24/2021 Decision Date05/13/2022 Product Code MIH Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS099 Date Received04/28/2022 Decision Date05/09/2022 Product Code MLV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS034 Date Received02/11/2022 Decision Date03/18/2022 Product Code PRL Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC3450 West Kiltie Ln.p.o. Box 500flagstaff, AZ 86002-0500 PMA NumberP040037 Supplement NumberS153 Date Received02/23/2022 Decision Date03/03/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC3250 W.kiltie Laneflagstaff, AZ 86001 PMA NumberP130006 Supplement NumberS092 Date Received02/23/2022 Decision Date03/03/2022 Product Code PFV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore And Associates, Inc.32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP200030 Supplement NumberS007 Date Received01/20/2022 Decision Date02/22/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. GORE & ASSOCIATES, INC.32360 N North Valley Parkwayphoenix, AZ 85085 PMA NumberP040027 Supplement NumberS090 Date Received01/20/2022 Decision Date02/22/2022 Product Code MIR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS098 Date Received01/20/2022 Decision Date02/22/2022 Product Code MLV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC3250 W.kiltie Laneflagstaff, AZ 86001 PMA NumberP130006 Supplement NumberS089 Date Received01/20/2022 Decision Date02/22/2022 Product Code PFV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W.L. GORE & ASSOCIATES,INC3450 West Kiltie Ln.p.o. Box 500flagstaff, AZ 86002-0500 PMA NumberP040037 Supplement NumberS150 Date Received01/20/2022 Decision Date02/22/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS033 Date Received01/20/2022 Decision Date02/22/2022 Product Code PRL Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
W. L. GORE & ASSOCIATES, INC.3450 Kiltie Lanep.o. Box 2400flagstaff, AZ 86003-2400 PMA NumberP040043 Supplement NumberS130 Date Received01/20/2022 Decision Date02/22/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020032326683	Hong Kong,Hong Kong -> Oakland, California	SEAMTAPE . . . . .	3 CTN
2019102139414	Hong Kong,Hong Kong -> Oakland, California	LAMINATED FABRIC ORDER NUMBER(S) 28415592	2 PKG
2019082257625	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	DORLASTAN FILAMENT V550 SECTIONAL BEAMS 21X21 DTEX 135 (122 DEN) MERGE 1179 DELIVERY NOTE 80163964 = 4 ROLLS ON 1 PALLET HS-CODE 540244	4 PKG
2019042947643	Puerto Limon,Costa Rica -> Wilmington, Delaware	FILTER BAGS	376 BOX
2019042512165	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	HTS 392119 UBNPRINTED SHEET FILM	17 CTN
2019042352659	London,United Kingdom -> New York, New York	TEXTILE	5 PCS
2019042231159	Puerto Limon,Costa Rica -> Wilmington, Delaware	FILTER BAGS	370 BOX
2019042231160	Puerto Limon,Costa Rica -> Wilmington, Delaware	FILTER BAGS	138 BOX

NCAGE Code	Z8Z00	W L GORE & ASSOCIATES
NCAGE Code	ENJ61	W L GORE & ASSOCIATES
CAGE Code	ENJ61	W L GORE & ASSOCIATES
CAGE Code	Z8Z00	W L GORE & ASSOCIATES