| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3021836309 | 3021836309 | Saluda Medical Pty. Ltd. | 1 | N | 2026-01-01 | 5 Eden Park Drive Macquarie Park New South Wales AU 2113 |
| 3012939358 | 3012939358 | SALUDA MEDICAL PTY LTD | 1 | N | 2020-04-25 | 407 Pacific Highway Artarmon New South Wales AU 2064 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 308112 | 1741351280 | P190002 | Saluda Medical Evoke SCS System | LGW | 2022-02-28 |
| 235176 | 1765969216 | ||||
| 308112 | 1429419121 | ||||
| 308112 | 1765969216 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LGW | 1 | 2022-02-28 |
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...
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...
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...
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...
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...
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 Ch...
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 Ch...
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 Ch...
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 Reaso...
SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Date Received01/22/2019 Decision Date02/28/2022 Product Code LGW Advisory Committee Neurology Clinical TrialsNCT02924129 Expedited Review Granted? No
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