Saluda Medical Pty L T D

FDA Filings

This page includes the latest FDA filings for Saluda Medical Pty 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: 3012939358
• FEI Number: 3012939358
• Name: SALUDA MEDICAL PTY LTD
• Owner & Operator: Saluda Medical Pty Ltd
• Contact Address: 407 Pacific Highway ; Artarmon AU-NSW New South Wales 2064 AU
• Official Correspondent:
  • Parmjeet Gill
  • 61-2-84058-747
• US Agent:
  • Kathy Mah
  • Saluda Medical
  • 650 7042863
  • kathy.mah@saludamedical.com
• Importing Logistics Registration:
  • Importer: SALUDA MEDICAL AMERICAS INC
  • Address: 9401 James Ave S, Suite 132 ; Bloomington, MN 55431 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 407 Pacific Highway ; Artarmon New South Wales, 2064 AU
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 09352307001817 SALUDA MEDICAL PTY LIMITED	Evoke® Active Anchor Kit - L 3043	2024-03-28
GUDID 09352307001718 SALUDA MEDICAL PTY LIMITED	Evoke® Active Anchor Kit	2023-10-18
GUDID 09352307001701 SALUDA MEDICAL PTY LIMITED	Evoke® Spares Kit	2023-10-18
GUDID 09352307001695 SALUDA MEDICAL PTY LIMITED	Evoke® Spares Kit	2023-10-18
GUDID 09352307001671 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12X Lead Extension Kit - 55 cm	2023-10-18
GUDID 09352307001657 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Percutaneous Lead Kit - 90 cm	2023-10-18
GUDID 09352307001640 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Percutaneous Lead Kit - 60 cm	2023-10-18
GUDID 09352307001633 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Percutaneous Lead Kit - 90 cm	2023-10-18
GUDID 09352307001626 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Percutaneous Lead Kit - 60 cm	2023-10-18
GUDID 09352307001572 SALUDA MEDICAL PTY LIMITED	Evoke® Closed-Loop Stimulator (CLS)	2023-10-18
GUDID 09352307001565 SALUDA MEDICAL PTY LIMITED	Evoke® Closed-Loop Stimulator (CLS)	2023-10-18
GUDID 09352307000759 SALUDA MEDICAL PTY LIMITED	Evoke® Closed-Loop Stimulator (CLS) 3042	2023-07-19
GUDID 09352307001688 SALUDA MEDICAL PTY LIMITED	Evoke® Spares Kit 3015	2023-01-12
GUDID 09352307001664 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12X Lead Extension Kit - 55 cm 3011	2023-01-12
GUDID 09352307001619 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Trial Percutaneous Lead Kit - 90 cm 3017	2023-01-12
GUDID 09352307001602 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Trial Percutaneous Lead Kit - 60 cm 3016	2023-01-12
GUDID 09352307001596 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Percutaneous Lead Kit - 90 cm 3009	2023-01-12
GUDID 09352307001589 SALUDA MEDICAL PTY LIMITED	Evoke ® CAP12 Percutaneous Lead Kit - 60 cm 3008	2023-01-12
GUDID 09352307000872 SALUDA MEDICAL PTY LIMITED	Evoke® RECAP Viewer 3045	2023-01-12
GUDID 09352307000865 SALUDA MEDICAL PTY LIMITED	Evoke® Clarity™ Programming Application 3044	2023-01-12
GUDID 09352307000827 SALUDA MEDICAL PTY LIMITED	Evoke® Spares Kit 3015	2023-01-12
GUDID 09352307000810 SALUDA MEDICAL PTY LIMITED	Evoke® Active Anchor Kit 3043	2023-01-12
GUDID 09352307000803 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Trial Percutaneous Lead Kit - 90 cm 3017	2023-01-12
GUDID 09352307000797 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Trial Percutaneous Lead Kit - 60 cm 3016	2023-01-12
GUDID 09352307000780 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Percutaneous Lead Kit - 90 cm 3009	2023-01-12
GUDID 09352307000773 SALUDA MEDICAL PTY LIMITED	Evoke® CAP12 Percutaneous Lead Kit - 60 cm 3008	2023-01-12
GUDID 09352307001183 SALUDA MEDICAL PTY LIMITED	Evoke® Clinical Interface (CI) 3024	2022-12-07
GUDID 09352307001510 SALUDA MEDICAL PTY LIMITED	Evoke® Patient Controller (EPC) 3040	2022-11-04
GUDID 09352307000643 SALUDA MEDICAL PTY LIMITED	Evoke® 12C Percutaneous Trial Lead Kit - 90 cm 3017	2022-03-23
GUDID 09352307000414 SALUDA MEDICAL PTY LIMITED	Evoke® 12C Lead Extension Kit - 55cm 3011	2022-03-23
GUDID 09352307000407 SALUDA MEDICAL PTY LIMITED	Evoke® Accessory Belt 3039	2022-03-23
GUDID 09352307000384 SALUDA MEDICAL PTY LIMITED	Evoke® Intraoperative Cable Kit 3034	2022-03-23
GUDID 09352307000360 SALUDA MEDICAL PTY LIMITED	Evoke® eCLS Battery Charger Kit 3038	2022-03-23
GUDID 09352307000346 SALUDA MEDICAL PTY LIMITED	Evoke® External Closed-Loop Stimulator (eCLS) 3036	2022-03-23
GUDID 09352307000339 SALUDA MEDICAL PTY LIMITED	Evoke® External Closed-Loop Stimulator (eCLS) Case 3035	2022-03-23
GUDID 09352307000292 SALUDA MEDICAL PTY LIMITED	Evoke® Closed-Loop Stimulator (CLS) 3002	2022-03-23
GUDID 09352307000230 SALUDA MEDICAL PTY LIMITED	Evoke® Clinical Interface (CI) 3024	2022-03-23
GUDID 09352307000193 SALUDA MEDICAL PTY LIMITED	Evoke® 12C Percutaneous Trial Lead Kit - 60 cm 3016	2022-03-23
GUDID 09352307000179 SALUDA MEDICAL PTY LIMITED	Evoke® Spares Kit 3015	2022-03-23
GUDID 09352307000155 SALUDA MEDICAL PTY LIMITED	Evoke® Epidural Needle 6.5" 3014	2022-03-23
GUDID 09352307000131 SALUDA MEDICAL PTY LIMITED	Evoke® Tunnelling Tool 3012	2022-03-23
GUDID 09352307000100 SALUDA MEDICAL PTY LIMITED	Evoke® 12C Percutaneous Lead Kit - 90 cm 3009	2022-03-23
GUDID 09352307000087 SALUDA MEDICAL PTY LIMITED	Evoke® 12C Percutaneous Lead Kit - 60 cm 3008	2022-03-23
GUDID 09352307000063 SALUDA MEDICAL PTY LIMITED	Evoke® Charger 3006	2022-03-23
GUDID 09352307000049 SALUDA MEDICAL PTY LIMITED	Evoke® Clinical System Transceiver (CST) 3004	2022-03-23
GUDID 09352307000025 SALUDA MEDICAL PTY LIMITED	Evoke® Pocket Console (EPC) 3040	2022-03-23
LGW SALUDA MEDICAL PTY LTD	Evoke Tunneling Tool	2019-11-14
LGW SALUDA MEDICAL PTY LTD	Evoke Spares Kit	2019-11-14
LGW SALUDA MEDICAL PTY LTD	Evoke Lead Adapter Kit	2019-11-14
LGW SALUDA MEDICAL PTY LTD	Evoke Intraoperative Cable Kit	2019-11-14
LGW SALUDA MEDICAL PTY LTD	Evoke Epidural Needle, 6.5"	2019-11-14
LGW SALUDA MEDICAL PTY LTD	Evoke 12C Percutaneous Lead Kit - 90cm	2019-11-14
LGW SALUDA MEDICAL PTY LTD	Evoke 12C Percutaneous Lead Kit - 60cm	2019-11-14
LGW SALUDA MEDICAL PTY LTD	Evoke 12C Lead Extension Kit - 55cm	2019-11-14

Similar & Related FDA Registered Companies

• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS015 Date Received09/30/2022 Decision Date12/29/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS013 Date Received09/19/2022 Decision Date12/15/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS011 Date Received05/11/2022 Decision Date08/09/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS010 Date Received05/09/2022 Decision Date08/03/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS009 Date Received04/29/2022 Decision Date07/26/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS008 Date Received04/27/2022 Decision Date05/26/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS006 Date Received04/12/2022 Decision Date05/12/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS004 Date Received03/21/2022 Decision Date04/20/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS002 Date Received03/07/2022 Decision Date04/06/2022 Product Code LGW  Advisory Committee Neurology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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