E Life I N T Co L T D

FDA Filings

This page includes the latest FDA filings for E Life I N T Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005885000
• FEI Number: 3005885000
• Name: E-LIFE INTERNATIONAL CO., LTD
• Owner & Operator: E-LIFE INTERNATIONAL CO., LTD.
• Contact Address: 7F., No. 1, Baosheng Rd., Yonghe Dist.,; New Taipei City TW-NOTA 234 TW
• Official Correspondent:
  • Kenny Lee
  • 886-2-29231516-x
• US Agent:
  • Glenn Choi
  • ST&G USA Corporation
  • 714 5240663
  • 714 3648113
  • gchoi2001@yahoo.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7F., No.1, Baosheng Rd., ; Yonghe Dist., Taipei - Special Municipal, 234 TW
• Establishment Type: Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
NJB E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	Ankle walker	2008-06-27
MRI E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	Ankle/foot orthosis	2008-06-27
KNP E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	Orthosis corrective shoe	2008-06-27
IQF E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	with ridig pelvic pressure bar	2008-06-27
IQF E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	Hyperextension orthosis	2008-06-27
IOY E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	and brace	2008-06-27
IOY E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	Arm/wrist/shoulder support	2008-06-27
KIC E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	SILICON PAD	2007-12-14
KIC E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	BACK/HEEL/FOOT/TOE CUSHION AND	2007-12-14
ITW E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	ANKLE/THIGH/SHIN BRACE AND SUPPORT	2007-12-14
ITQ E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	KNEE IMMOBILIZER	2007-12-14
ITQ E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	HINGED KNEE/ELBOW BRACE &	2007-12-14
ITM E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	KNEE BRACE & FUNCTIONAL KNEE BRACE	2007-12-14
ISR E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	PELVIC SUPPORT	2007-12-14
IQM E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	FOLD-OVER FINGER SPLINT	2007-12-14
IQK E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	HYPEREXTENSION SPINAL ORTHOSIS	2007-12-14
IQJ E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	CLAVICLE BRACE, SPLINT, AND COLLAR	2007-12-14
IPY E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	ORTHOSIS, LUMBO-SACRAL	2007-12-14
IMD E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	COLD AND/OR HOT PAD	2007-12-14
ILI E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	ARM SLING AND SHOULDER IMMOBILIZER	2007-12-14
ILH E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	FINGER SPLINT	2007-12-14
ILE E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	COLLAR AND CUFF SLING	2007-12-14
HST E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	TRACTION AND EXERCISE PULLY	2007-12-14
IQI E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	NEXCARE LIMB	2006-06-21
IQE E-LIFE INTERNATIONAL CO., LTD [E-LIFE INTERNATIONAL CO., LTD.]	NEXCARE LUMBAR	2006-06-21

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• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS069 Date Received10/12/2022 Decision Date10/19/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS001 Date Received10/12/2022 Decision Date10/19/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS209 Date Received08/25/2022 Decision Date09/23/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Date Received03/14/2022 Decision Date09/14/2022 Product Code NKM  Advisory Committee Cardiovascular Clinical TrialsNCT03706833 Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS067 Date Received08/15/2022 Decision Date09/12/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS208 Date Received08/15/2022 Decision Date09/12/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS064 Date Received04/06/2022 Decision Date04/26/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS062 Date Received03/22/2022 Decision Date04/20/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS019 Date Received04/04/2022 Decision Date04/08/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS063 Date Received04/06/2022 Decision Date04/08/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS206 Date Received03/08/2022 Decision Date03/31/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS061 Date Received03/08/2022 Decision Date03/31/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS067 Date Received03/05/2014 Decision Date05/19/2014 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS066 Date Received02/27/2014 Decision Date03/27/2014 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS065 Date Received02/25/2014 Decision Date03/14/2014 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS064 Date Received12/24/2013 Decision Date01/23/2014 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS063 Date Received11/22/2013 Decision Date12/19/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS062 Date Received09/12/2013 Decision Date10/11/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS061 Date Received08/26/2013 Decision Date09/23/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS060 Date Received06/17/2013 Decision Date07/16/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS059 Date Received05/29/2013 Decision Date06/25/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS056 Date Received12/14/2012 Decision Date06/11/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS058 Date Received03/25/2013 Decision Date04/24/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS057 Date Received02/12/2013 Decision Date03/12/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS055 Date Received11/28/2012 Decision Date02/28/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS054 Date Received11/21/2012 Decision Date12/11/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS053 Date Received11/13/2012 Decision Date12/10/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS052 Date Received09/04/2012 Decision Date10/04/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS051 Date Received08/21/2012 Decision Date09/19/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS050 Date Received06/13/2012 Decision Date07/11/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS049 Date Received05/04/2012 Decision Date05/30/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS048 Date Received03/20/2012 Decision Date04/13/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS047 Date Received03/05/2012 Decision Date04/04/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS046 Date Received02/21/2012 Decision Date03/22/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS045 Date Received12/20/2011 Decision Date01/19/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS044 Date Received11/16/2011 Decision Date12/12/2011 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS040 Date Received11/12/2010 Decision Date07/27/2011 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS043 Date Received04/08/2011 Decision Date05/05/2011 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS042 Date Received12/21/2010 Decision Date01/20/2011 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS041 Date Received11/22/2010 Decision Date12/22/2010 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS039 Date Received01/25/2010 Decision Date02/24/2010 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS038 Date Received01/21/2010 Decision Date02/18/2010 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS037 Date Received12/17/2009 Decision Date01/14/2010 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS036 Date Received12/04/2009 Decision Date12/30/2009 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS035 Date Received10/19/2009 Decision Date11/25/2009 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS034 Date Received07/07/2009 Decision Date07/23/2009 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS033 Date Received06/22/2009 Decision Date07/09/2009 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS032 Date Received12/08/2008 Decision Date12/31/2008 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS031 Date Received11/28/2008 Decision Date12/17/2008 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS030 Date Received10/02/2008 Decision Date10/29/2008 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS029 Date Received06/20/2008 Decision Date07/10/2008 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS028 Date Received03/24/2008 Decision Date05/23/2008 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS027 Date Received11/15/2007 Decision Date12/13/2007 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS024 Date Received08/30/2006 Decision Date01/29/2007 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS025 Date Received09/26/2006 Decision Date01/18/2007 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS023 Date Received11/14/2005 Decision Date12/06/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS022 Date Received08/19/2005 Decision Date10/07/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS021 Date Received04/28/2005 Decision Date05/20/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS020 Date Received03/21/2005 Decision Date04/08/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS019 Date Received01/31/2005 Decision Date02/28/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS018 Date Received12/20/2004 Decision Date01/19/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS017 Date Received09/27/2004 Decision Date12/29/2004 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS015 Date Received11/12/2002 Decision Date08/22/2003 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS016 Date Received12/05/2002 Decision Date12/31/2002 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS014 Date Received07/13/2000 Decision Date08/04/2000 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS013 Date Received05/18/2000 Decision Date06/16/2000 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS012 Date Received10/04/1999 Decision Date10/22/1999 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS011 Date Received03/26/1999 Decision Date04/13/1999 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS010 Date Received10/09/1998 Decision Date10/26/1998 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS006 Date Received02/25/1998 Decision Date08/07/1998 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS002 Date Received10/30/1995 Decision Date12/06/1996 Withdrawal Date 01/28/2022 Product Code DYE  Docket Number N Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS003 Date Received04/17/1996 Decision Date10/17/1996 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Date Received09/24/1987 Decision Date09/25/1991 Withdrawal Date 01/28/2022 Product Code DYE  Docket Number 91M-0395 Notice Date 11/12/1991 Advisory Committee Cardiovascular Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092629904	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	ORTHOPEDIC SUPPORTS .	127 CTN
2020091850870	Xiamen,China (Mainland) -> Los Angeles, California	ORTHOPEDIC SUPPORTS	47 CTN
2020091785455	Xiamen,China (Mainland) -> Los Angeles, California	ORTHOPEDIC SUPPORTS	47 CTN
2020091656938	Xiamen,China (Mainland) -> Los Angeles, California	ORTHOPEDIC SUPPORTS	47 CTN
2020091558828	Xiamen,China (Mainland) -> Los Angeles, California	ORTHOPEDIC SUPPORTS	47 CTN
2020082153543	Xiamen,China (Mainland) -> Los Angeles, California	ORTHOPEDIC SUPPORTS	30 CTN
2020082026904	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	ORTHOPEDIC SUPPORTS HS CODE9021.10 AMS SCAC OSU MBL NOCOSU6269168950 THIS SHIPMENT CONTA INS NO SOLID WOOD PACKING MATERIAL	433 CTN
2020081869149	Xiamen,China (Mainland) -> Los Angeles, California	ORTHOPEDIC SUPPORTS	30 CTN