Medtronic Cryocath L P

FDA Filings

This page includes the latest FDA filings for Medtronic Cryocath L P. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3002648230
FEI Number	3002648230
Name	Medtronic CryoCath LP
Owner & Operator	MEDTRONIC INC.
Contact Address	710 Medtronic Pkwy. Minneapolis MN 55432 US
Official Correspondent	CHRISTINE - BOES x-763-5260396-x
US Agent	N/A N/A 0 N/A
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	9000 Autoroute Transcanadienne Pointe-Claire Quebec, H9R 5Z8 CA
Establishment Type	Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMA P100010S124 Medtronic CryoCath LP	Arctic Front Advance, Arctic Front Advance Pro TM Cardiac Cryoablation Catheter	2022-01-20
PMA P100010S122 Medtronic CryoCath LP	Arctic Front Advance, Arctic Front Advance Pro	2021-12-07
PMA P100010S121 Medtronic CryoCath LP	Arctic Front Advance®, Arctic Front Advance Pro® Cardiac CryoAblation Catheters	2021-11-17
PMA P100010S120 Medtronic CryoCath LP	Arctic Front Advance Cardiac Cryoablation Catheter; Arctic Front Advance Pro Cardiac Cryoablation Catheter	2021-11-09
PMA P100010S119 Medtronic CryoCath LP	Arctic Front® Advance Cardiac Cryoablation Catheter	2021-11-05
PMA P100010S117 Medtronic CryoCath LP	Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit	2021-09-10
PMA P020045S099 Medtronic CryoCath LP	Freezor Xtra Cardiac Cryoablation Catheter	2021-08-22
PMA P100010S116 Medtronic CryoCath LP	Arctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe	2021-08-06
PMA P020045S096 Medtronic CryoCath LP	7F Freezor Cardiac CryoablationCatheter and CCT.2 Cryoconsole System	2021-06-01
PMA P100010S115 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2021-05-13
PMA P020045S094 Medtronic CryoCath LP	7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter, 9F Freezor MAX Cardiac Cryoabla	2021-03-17
PMA P100010S113 Medtronic CryoCath LP	Arctic Front Advance and Arctic Front Advance Pro	2021-03-03
PMA P100010S112 Medtronic CryoCath LP	Arctic Front Advance and Arctic Front Advance Pro	2020-12-15
PMA P100010S111 Medtronic CryoCath LP	Artic Front Advance and Artic Front Advance Pro Cryoablation Catheter	2020-12-15
PMN K202620 Medtronic CryoCath LP	FlexCath Advance Steerable Sheath And Dilator	2020-11-13
PMA P100010S109 Medtronic CryoCath LP	Arctic Front Advance and Arctic Front Pro Catheters Shaft Components	2020-11-09
PMA P100010S107 Medtronic CryoCath LP	Arctic Front Cryocatheter System	2020-08-13
PMA P100010S106 Medtronic CryoCath LP	Artic Front Advance Pro Cardiac Cryoablation Catheter	2020-06-25
PMA P100010S105 Medtronic CryoCath LP	Artic Front Advance Pro Cardiac Cryoablation Catheter	2020-06-18
PMA P100010S104 Medtronic CryoCath LP	Arctic Front Advance Cardiac Cryoablation Catheter	2020-05-20
PMA P100010S102 Medtronic CryoCath LP	Artic Front Advance Pro Cardiac Cryoablation Catheters	2020-03-05
PMA P100010S103 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2020-02-24
PMA P100010S101 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2020-02-03
PMA P020045S093 Medtronic CryoCath LP	Freezor, Arctic Front Advance (AFA) CryoAblation Catheters	2020-02-03
PMA P100010S100 Medtronic CryoCath LP	Arctic Front Advance Pro Cryoballoon Catheter	2020-01-17
PMA P100010S099 Medtronic CryoCath LP	Arctic Front Advance and Arctic Front Advance Pro	2019-12-10
PMA P100010S097 Medtronic CryoCath LP	Arctic Front Advance Pro and Arctic Front Advance Cardiac Cryoablation Catheters	2019-10-18
PMA P020045S090 Medtronic CryoCath LP	Freezor Cardiac Cryoablation System	2019-10-09
PMA P100010S096 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2019-09-19
PMA P100010S093 Medtronic CryoCath LP	Artic Front Advance Pro Cardiac Cryoablation Catheter	2019-06-27
PMA P100010S095 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2019-06-17
PMA P100010S094 Medtronic CryoCath LP	Arctic Front Advance Cardiac Cryoablation Catheters	2019-06-04
PMA P100010S092 Medtronic CryoCath LP	Artic Front Advance Cardiac CryoAblation Catheters	2019-05-08
PMA P100010S091 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2019-05-03
PMA P100010S086 Medtronic CryoCath LP	Arctic Front, Front Advance Cardiac Cryoablation, Freezor MAX & CryoConsoleSystem	2019-05-01
PMA P100010S089 Medtronic CryoCath LP	Arctic Fron Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters	2019-04-03
PMA P100010S088 Medtronic CryoCath LP	Arctic Front Advance Cardiac Cryoablation Catheter	2019-03-05
PMN K183174 \| DRA Medtronic CryoCath LP [MEDTRONIC INC.]	FlexCath Advance	2019-02-19
PMA P100010S087 Medtronic CryoCath LP	Arctic Front Advance Pro Cardiac Cryoablation Catheter	2019-01-03
PMN K183174 Medtronic CryoCath LP	FlexCath Advance Steerable Sheath And Dilator	2018-11-26
PMA P100010S084 Medtronic CryoCath LP	Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters	2018-11-09
PMA P100010S085 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2018-09-25
PMA P100010S082 Medtronic CryoCath LP	Arctic Front Advance Cardiac Cryoablation Catheter	2018-09-25
PMA P100010S083 Medtronic CryoCath LP	Arctic Front Advance Pro Cardiac Cryoablation Catheter	2018-09-24
PMA P020045S089 Medtronic CryoCath LP	CryoConsole	2018-08-10
PMA P100010S081 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2018-08-07
PMA P100010S080 Medtronic CryoCath LP	Artic Front Advance Cardiac Cryoablation Catheter, 23/28mm, US	2018-07-26
PMA P100010S079 Medtronic CryoCath LP	Freezor MAX Cardiac Cryoablation Catheter	2018-07-12
PMA P020045S088 Medtronic CryoCath LP	Freezor Cardiac Cryoablation Catheter; Freezor Xtra Surgical Cardiac Cryoablation ; Freezor MAX Cardiac Cryoablati	2018-07-12
PMA P100010S076 Medtronic CryoCath LP	Gen V CryoConsole RoHS Compliant	2018-05-04
PMA P100010S070 Medtronic CryoCath LP	Arctic Front Advance Pro Cardiac Cryoablation Catheter	2018-05-04
PMA P020045S087 Medtronic CryoCath LP	Gen V CryoConsole	2018-05-04
PMA P100010S078 Medtronic CryoCath LP	Artic Front Advance Cardiac CryoAblation Catheter	2018-04-25
PMA P100010S077 Medtronic CryoCath LP	Artic Front Advance Cardiac CryoAblation Catheters	2018-04-23
PMA P100010S073 Medtronic CryoCath LP	Arctic Front Cardiac CryoAblation Catheter and Arctic Front Advance Cardiac CryoAblation Catheter	2018-04-17
PMA P020045S086 Medtronic CryoCath LP	Freezor Cardiac CryoAblation Catheter, Freezor Xtra Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation	2018-04-17
PMA P100010S075 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheter	2018-03-15
PMA P100010S074 Medtronic CryoCath LP	Arctic Front Advance Cardiac Cryoablation Catheter	2018-03-09
PMA P100010S071 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheter	2018-02-28
PMA P100010S072 Medtronic CryoCath LP	Freezor MAX	2018-02-06
PMA P020045S085 Medtronic CryoCath LP	Freezor Cardiac Cryoablation Catheter (4-mm tip), Freezor Xtra Surgical Cardiac Cryoablation (6-mm tip), Freezor	2018-02-06
PMA P100010S069 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2017-12-14
PMA P100010S068 Medtronic CryoCath LP	Arctic Front Cardiac CryoAblation System	2017-11-27
PMA P020045S084 Medtronic CryoCath LP	Freezor Cardiac CryoAblation System	2017-11-27
PMA P100010S065 Medtronic CryoCath LP	Arctic Front Cryoablation System (CryoConsole)	2017-10-03
PMA P020045S083 Medtronic CryoCath LP	Freezor CryoAblation System (CryoConsole)	2017-10-03
PMA P100010S066 Medtronic CryoCath LP	Arctic Front Advance Catheters	2017-08-31
PMA P100010S067 Medtronic CryoCath LP	Visual Integrity Inspection	2017-08-22
PMN K163268 \| DYB Medtronic CryoCath LP [MEDTRONIC INC.]	FlexCath Select	2017-05-08
PMA P100010S064 Medtronic CryoCath LP	Arctic Front and Arctic Front Advance Cardiac CryoAlbation Catheters	2017-04-21
PMA P100010S063 Medtronic CryoCath LP	Arctic Front Family of Catheters	2017-04-17
PMA P020045S082 Medtronic CryoCath LP	Freezer Cardiac Cryoablation, Freezer Xtra Surgical Cardiac, Freezer MAX Surgical Cardiac	2017-04-17
PMA P100010S062 Medtronic CryoCath LP	Arctic Front Catheter, Arctic Front Advance Catheter, Arctic Front Advance ST Catheter, Freezor MAX Catheter, Manual ret	2017-03-22
PMA P020045S081 Medtronic CryoCath LP	Freezor Catheter, Freezor Xtra Catheter, Freezor MAX Surgical , Electrical umbilical cable, Coaxial umbilical cabl	2017-03-22
PMA P020045S080 Medtronic CryoCath LP	Coaxial Umbilical Cable	2017-03-20
PMN K163268 Medtronic CryoCath LP	FlexCath Select Steerable Shealth And Dilator	2017-02-02
PMA P100010S060 Medtronic CryoCath LP	ARCTIC FRONT CRYOCATHETER SYSTEM	2017-01-17
PMA P020045S078 Medtronic CryoCath LP	Freezor CryoAblation System	2017-01-17
PMA P100010S061 Medtronic CryoCath LP	ARCTIC FRONT & ARCTIC ADVANCED CARDIAC CRYOABLATIN CATHETER SYSTEM	2017-01-06
PMA P100010S059 Medtronic CryoCath LP	FREEZOR MAX CARDIAC CRYOABLATION CATHETER, AROTIC FRONT/AROTIC FRONT ADVANCE /AROTIC FRONT ADVANCE ST CARDIAC CRYOABLATI	2016-11-17
PMA P020045S077 Medtronic CryoCath LP	FREEZOR CARDIAC CRYOABLATION CATHETER /XTRA SUGICAL/ MAX SURGICAL CARDIA CRYOABLATION DEVICES, STERILE ACCESSORIES COAX	2016-11-17
PMA P100010S058 Medtronic CryoCath LP	ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM: 23MM AND 28MM ARCTIC FRONT CATHETERS, FREEZOR MAX CATHETER, CRYOCONSOLE, MANUA	2016-08-31
PMA P020045S073 Medtronic CryoCath LP	FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE	2016-08-31
PMA P100010S056 Medtronic CryoCath LP	ARCTIC FRONT CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ST CARDIAC	2016-07-29
PMA P020045S075 Medtronic CryoCath LP	FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CATHETERS, FREEZOR MAX SURGICAL CATHETER	2016-07-29
PMA P100010S057 Medtronic CryoCath LP	ARCTIC FRONT FAMILY CARDIAC CRYOABLATION CATHETERS	2016-07-07
PMA P020045S076 Medtronic CryoCath LP	FREEZOR FAMILY CARDIAC CRYOABLATION CATHETERS	2016-07-07
PMA P100010S054 Medtronic CryoCath LP	Arctic Front Advance Cardiac CryoAblation Catheters	2016-05-17
PMA P100010S053 Medtronic CryoCath LP	ARCTIC FRONT CRYOCATHETER SYSTEM	2016-03-11
PMA P020045S074 Medtronic CryoCath LP	7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM	2016-03-11
PMA P020045S072 Medtronic CryoCath LP	FREEZOR CARDIAC CRYOABLATION SYSTEM	2016-01-27
PMA P020045S071 Medtronic CryoCath LP	FREEZOR CARDIAC CRYOABLATION SYSTEM	2016-01-14
OAE Medtronic CryoCath LP [MEDTRONIC INC.]	PVAC GOLD, MASC, MAAC	2015-09-25
OAE Medtronic CryoCath LP [MEDTRONIC INC.]	GENius RF Generator	2015-09-25
OAE Medtronic CryoCath LP [MEDTRONIC INC.]	GENius Jr. Remote Control	2015-09-25
OAE Medtronic CryoCath LP [MEDTRONIC INC.]	ECG Interface Box 990028, Cables 990020, 990027, 990041, 990042	2015-09-25
PMN K142684 \| DYB Medtronic CryoCath LP [MEDTRONIC INC.]	FlexCath Select Steerable sheath	2014-11-24
PMN K142684 Medtronic CryoCath LP	FlexCath Select Steerable Sheath (10 French)	2014-11-06
PMN P100010 \| OAE Medtronic CryoCath LP [MEDTRONIC INC.]	Freezor MAX cardiac cryoablation catheter	2013-03-28
PMN P100010 \| OAE Medtronic CryoCath LP [MEDTRONIC INC.]	Arctic Front cardiac cryoablation catheter	2013-03-28
PMN P100010 \| OAE Medtronic CryoCath LP [MEDTRONIC INC.]	Arctic Front Advance cardiac cryoablation catheter	2013-03-28
PMN P100010 \| OAE Medtronic CryoCath LP [MEDTRONIC INC.]	Arctic Front Advance ProTM	2013-03-28
PMN P020045 \| LPB Medtronic CryoCath LP [MEDTRONIC INC.]	Freezor cardiac cryoablation catheter	2013-03-28
PMN P020045 \| LPB Medtronic CryoCath LP [MEDTRONIC INC.]	Freezor Xtra cardiac cryoablation catheter	2013-03-28
PMN P020045 \| LPB Medtronic CryoCath LP [MEDTRONIC INC.]	Freezor Xtra Surgical cardiac cryoablation catheter	2013-03-28
PMN P020045 \| LPB Medtronic CryoCath LP [MEDTRONIC INC.]	Freezor MAX Surgical cryoablation catheter	2013-03-28
PMN P020045 \| LPB Medtronic CryoCath LP [MEDTRONIC INC.]	ECG Cable	2013-03-28
PMN P020045 \| LPB Medtronic CryoCath LP [MEDTRONIC INC.]	Cryoconsole	2013-03-28
PMN P020045 \| LPB Medtronic CryoCath LP [MEDTRONIC INC.]	Coaxial Cable	2013-03-28
PMN K123591 \| DRA Medtronic CryoCath LP [MEDTRONIC INC.]	FlexCath Advance	2013-03-28
PMN K102176 \| DRA Medtronic CryoCath LP [MEDTRONIC INC.]	FlexCath Steerable Sheath	2013-03-28
PMN K081049 \| DRA Medtronic CryoCath LP [MEDTRONIC INC.]	FlexCath Steerable Sheath	2013-03-28
LPB Medtronic CryoCath LP [MEDTRONIC INC.]	SPRINKLR	2013-03-17
LPB Medtronic CryoCath LP [MEDTRONIC INC.]	RF Power Generator Adaptor Cable	2013-03-17
LPB Medtronic CryoCath LP [MEDTRONIC INC.]	RF Marinr	2013-03-17
LPB Medtronic CryoCath LP [MEDTRONIC INC.]	RF Conductr	2013-03-17
LPB Medtronic CryoCath LP [MEDTRONIC INC.]	Dual Dispersive Electrode Cable	2013-03-17
LPB Medtronic CryoCath LP [MEDTRONIC INC.]	CryoConsole	2013-03-17
LPB Medtronic CryoCath LP [MEDTRONIC INC.]	ATAKR Plus	2013-03-17
PMN K123591 MEDTRONIC CRYOCATH LP	FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)	2012-12-27
PMN K102176 MEDTRONIC CRYOCATH LP	FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10	2010-09-01

Similar & Related FDA Registered Companies

Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS135 Date Received12/22/2022 Decision Date01/19/2023 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP020045 Supplement NumberS102 Date Received12/22/2022 Decision Date01/19/2023 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS134 Date Received12/21/2022 Decision Date01/19/2023 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS133 Date Received11/14/2022 Decision Date12/07/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS132 Date Received10/28/2022 Decision Date11/09/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS130 Date Received08/24/2022 Decision Date09/23/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS129 Date Received07/25/2022 Decision Date08/24/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP020045 Supplement NumberS101 Date Received07/25/2022 Decision Date08/24/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS128 Date Received05/20/2022 Decision Date06/01/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS127 Date Received04/25/2022 Decision Date05/06/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS125 Date Received02/14/2022 Decision Date03/16/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP020045 Supplement NumberS100 Date Received02/16/2022 Decision Date03/15/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS126 Date Received02/16/2022 Decision Date03/15/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	L4060	MEDTRONIC CRYOCATH LP^DBA CRYOCATH TECHNOLOGY
CAGE Code	L4060	MEDTRONIC CRYOCATH LP CRYOCATH TECHNOLOGY