FDA.reportPublic FDA data

Endologix LLC

Matched from indexed company URL: ENDOLOGIX INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30080112473008011247Endologix LLC1N2026-01-013910 Brickway Blvd Santa Rosa CA US 95403
30110632233011063223Endologix LLC1N2026-01-0135 Hammond Irvine CA US 92618
30153659043015365904Endologix LLC1N2026-01-011971 Milmont Dr Milpitas CA US 95035
30131623473013162347Endologix International Holdings B.V.1N2020-04-25Europalaan 30 Hertogenbosch Noord-Brabant NL 5232 BC's

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850007370329Ovation iX Iliac Stent Graft - The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.(949) 595-7200CustomerService@endologix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2242361993117952P220021DETOUR SystemQWM2023-06-07
3184651993117952P220021DETOUR SystemQWM2023-06-07
2242361962862557P120006OVATION ABDOMINAL STENT GRAFT SYSTEMMIH2012-10-05
1753601433534800P040002ENDOLOGIX POWERLINK SYSTEMMIH2004-10-29
1973801433534800P040002ENDOLOGIX POWERLINK SYSTEMMIH2004-10-29
1753601301735027K991601DUAL LUMEN CATHETER, MODEL DL-35-90DQY1999-10-28
1973801301735027K991601DUAL LUMEN CATHETER, MODEL DL-35-90DQY1999-10-28
1753601587415105K120212AFX INTRODUCER SYSTEMDYB2012-02-09
1973801587415105K120212AFX INTRODUCER SYSTEMDYB2012-02-09
2242361097912016H100008

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MIH32012-10-05
DYB22012-02-09
DQY21999-10-28

PMA#

Alto Abdominal Stent Graft System

2022-12-22

Endologix, LLC3910 Brickway Blvdsanta Rosa, CA 95403 PMA NumberP120006 Supplement NumberS041 Date Received12/02/2022 Decision Date12/22/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - ...

AFX2 Endovascular AAA System

2022-12-06

Endologix, LLC2 Musickirvine, CA 92618 PMA NumberP040002 Supplement NumberS070 Date Received03/15/2022 Decision Date12/06/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indica...

74 records. Showing 1-40. Next

PMN#

GUDID#

Alto™ Abdominal Stent Graft System - """The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2."""

Endologix LLC

2023-02-28

Alto™ Abdominal Stent Graft System - """The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2."""

Endologix LLC

2023-02-28

Alto™ Abdominal Stent Graft System - """The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2."""

Endologix LLC

2023-02-28

Alto™ Abdominal Stent Graft System - """The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2."""

Endologix LLC

2023-02-28

Alto™ Abdominal Stent Graft System - """The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.The Alto™ Abdominal Stent Graft System includes: an Aortic Body Stent Graft and delivery catheter, Ovation iX™ Iliac Limb Stent Grafts and delivery catheters, Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required), the CustomSeal™ Polymer Fill Kit, and the Autoinjector 2."""

Endologix LLC

2023-02-28

81 records. Showing 1-40. Next