| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2182207 | 2182207 | MEDTRONIC NEUROMODULATION | 1 | N | 2026-01-01 | 7000 Central Ave., N.E. Minneapolis MN US 55432 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 102864 | 1382056634 | P990034 | MEDTRONIC ISOMED INFUSION SYSTEM | LKK | 2000-07-21 |
| 102864 | 1865359843 | P970004 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL | EZW | 1997-09-29 |
| 102864 | 1423819233 | P960009 | MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM | MHY | 1997-07-31 |
| 102864 | 1458099229 | P860004 | MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM | LKK | 1988-03-14 |
| 102864 | 1747154182 | P840001 | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS | LGW | 1984-11-30 |
| 102864 | 1282547309 | P240011 | Medtronic Altaviva System | QPT | 2025-09-18 |
| 102864 | 1971537090 | P080025 | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM | QON | 2011-03-14 |
| 102864 | 1308615135 | K994097 | MEDAMICUS EPIDURAL INTRODUCER | GZB | 2000-03-01 |
| 102864 | 1171302462 | K960631 | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX | GZF | 1996-05-21 |
| 102864 | 1705595047 | K923567 | MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD | GZB | 1992-11-05 |
| 102864 | 1177944408 | K132561 | NURO NEUROMODULATION SYSTEM | NAM | 2013-11-05 |
| 102864 | 1328357988 | K102523 | MULTI-LEAD TRIALING CABLE MODEL 355531 | GZB | 2010-10-26 |
| 102864 | 1288591407 | K062041 | MODEL 3875 1 X 8 SC TEST STIMULATION LEAD | GZB | 2006-08-16 |
| 102864 | 1491446915 | K051773 | MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS | GZB | 2005-07-28 |
| 102864 | 1636234522 | K040568 | POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS | GZB | 2004-03-25 |
| 102864 | 1423989226 | K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | HAW | 2004-10-04 |
| 102864 | 1234865614 | K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | HAW | 2004-03-02 |
| 102864 | 1502487385 | K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | HBL | 2003-08-21 |
| 102864 | 1984213119 | K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 | HAW | 2002-09-25 |
| 102864 | 1513233522 | K013120 | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 | GZB | 2002-01-24 |
| 102864 | 1452829244 | K012366 | NAVIGUS II TRAJECTORY GUIDE | HAW | 2001-10-01 |
| 102864 | 1055104641 | K001096 | BURR HOLE COVER, MODEL XX | GXR | 2000-10-25 |
| 102864 | 1519405913 | K000105 | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), | GZF | 2000-04-12 |
| 102864 | 1001878378 | H990014 | |||
| 102864 | 1456529414 | H050003 | |||
| 102864 | 1490604411 | H020007 | |||
| 102864 | 1591123371 | DEN210003 | SureTune4 Software | QQC | 2021-08-23 |
| 102864 | 1085522967 | ||||
| 102864 | 1225235528 | ||||
| 102864 | 1669083042 | ||||
| 102864 | 1684260090 | ||||
| 102864 | 1743536426 | ||||
| 102864 | 1948594558 |
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS536 Date Received01/20/2023 Decision Date02/02/2023 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS273 Date Received11/23/2022 Decision Date12/08/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS534 Date Received11/23/2022 Decision Date12/08/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS378 Date Received11/23/2022 Decision Date12/08/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS376 Date Received11/08/2022 Decision Date11/22/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS532 Date Received11/08/2022 Decision Date11/22/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS377 Date Received11/14/2022 Decision Date11/22/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS272 Date Received11/14/2022 Decision Date11/22/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS533 Date Received11/14/2022 Decision Date11/22/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS271 Date Received11/08/2022 Decision Date11/22/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS375 Date Received10/18/2022 Decision Date11/16/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS270 Date Received10/18/2022 Decision Date11/16/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS531 Date Received10/18/2022 Decision Date11/16/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS374 Date Received09/27/2022 Decision Date10/27/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Typespecial (immediate T...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS269 Date Received09/27/2022 Decision Date10/27/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Typespecial (immed...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS530 Date Received10/12/2022 Decision Date10/21/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS528 Date Received08/31/2022 Decision Date09/13/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS373 Date Received08/31/2022 Decision Date09/13/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS268 Date Received08/31/2022 Decision Date09/13/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS526 Date Received08/10/2022 Decision Date09/07/2022 Product Codes QRW LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason P...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS524 Date Received08/04/2022 Decision Date08/26/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS372 Date Received08/04/2022 Decision Date08/26/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS267 Date Received08/04/2022 Decision Date08/26/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS266 Date Received07/20/2022 Decision Date07/28/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS522 Date Received07/20/2022 Decision Date07/28/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS371 Date Received07/20/2022 Decision Date07/28/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS369 Date Received06/29/2022 Decision Date07/08/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS264 Date Received06/29/2022 Decision Date07/08/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS365 Date Received05/13/2022 Decision Date06/09/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS521 Date Received05/26/2022 Decision Date06/02/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS261 Date Received05/20/2022 Decision Date06/01/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS258 Date Received05/06/2022 Decision Date06/01/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS363 Date Received05/06/2022 Decision Date06/01/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS520 Date Received05/20/2022 Decision Date06/01/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS366 Date Received05/20/2022 Decision Date06/01/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS518 Date Received05/12/2022 Decision Date05/25/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS517 Date Received05/11/2022 Decision Date05/24/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS257 Date Received05/03/2022 Decision Date05/12/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS362 Date Received05/03/2022 Decision Date05/12/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS516 Date Received05/03/2022 Decision Date05/12/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...