MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS513 Date Received01/23/2023 Decision Date02/03/2023 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Matched from indexed company URL: MEDTRONIC Inc.

PMA

Consulta CRT-P, Syncra CRT-P

2023-02-03

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS513 Date Received01/23/2023 Decision Date02/03/2023 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG

2023-02-03

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS739 Date Received01/23/2023 Decision Date02/03/2023 Product Code NVZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Activa® Deep Brain Stimulation Therapy System

2023-02-02

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS446 Date Received01/20/2023 Decision Date02/02/2023 Product Code MHY Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

2023-01-17

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS738 Date Received01/09/2023 Decision Date01/17/2023 Product Code NVZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

2023-01-17

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS512 Date Received01/09/2023 Decision Date01/17/2023 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Sprint Quattro Lead

2023-01-16

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP920015 Supplement NumberS274 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVY Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M

2023-01-16

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS737 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

2023-01-04

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS736 Date Received12/15/2022 Decision Date01/04/2023 Product Code NVZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Micra AV TPS, Micra TPS

2022-12-12

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS164 Date Received12/06/2022 Decision Date12/12/2022 Product Code PNJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

2022-12-08

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP860004 Supplement NumberS403 Date Received11/23/2022 Decision Date12/08/2022 Product Code LKK Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Proce...

Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

2022-12-08

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS444 Date Received11/23/2022 Decision Date12/08/2022 Product Code MHY Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

MiniMed Enlite Sensor

2022-12-08

MEDTRONIC Inc.18000 Devonshire Streetnorthridge, CA 91325-1219 PMA NumberP120010 Supplement NumberS142 Date Received11/04/2022 Decision Date12/08/2022 Product Code OZO Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Pro...

SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

2022-12-02

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP860004 Supplement NumberS402 Date Received11/07/2022 Decision Date12/02/2022 Product Code LKK Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Proce...

IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated

2022-12-01

MEDTRONIC Inc.3576 Unocal Plsanta Rosa, CA 95403 PMA NumberP140010 Supplement NumberS071 Date Received11/29/2022 Decision Date12/01/2022 Product Code ONU Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...

Medtronic Melody Transcatheter Pulmonic Valve System

2022-11-28

MEDTRONIC Inc.8200 Coral Sea Street Nemvs83mounds View, MN 55112 PMA NumberP140017 Supplement NumberS023 Date Received11/16/2022 Decision Date11/28/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

Micra AV TPS, Micra TPS

2022-11-28

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS163 Date Received11/21/2022 Decision Date11/28/2022 Product Code PNJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

2022-11-22

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS442 Date Received11/08/2022 Decision Date11/22/2022 Product Code MHY Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena

2022-11-22

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS510 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

2022-11-22

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS443 Date Received11/14/2022 Decision Date11/22/2022 Product Code MHY Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

Transvene CS/SVC Lead

2022-11-22

MEDTRONIC Inc.8200 Coral Sea Streetms Mvs11mounds View, MN 55112 PMA NumberP980050 Supplement NumberS139 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWS Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

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