FDA.reportPublic FDA data

Autoinjector 2

Primary DI
M701TVAI01N1
Brand
Autoinjector 2
Company
Endologix LLC
Model
TV-AI01-N
Catalog number
TV-AI01-N
Device description
The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe plunger of the CustomSeal Kit to inject the fill polymer into the graft until pressure equilibrium is reached and complete fill of the primary sealing ring, fill channels, and support rings in the graft material the of the aortic body is achieved.
Published
2020-11-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120006000OVATION ABDOMINAL STENT GRAFT SYSTEMEndologix, LLC2012-10-05MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M701TVAI01N1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal aorta endovascular stent-graftA non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(949) 595-7200CustomerService@endologix.com

Regulatory Flags#

DUNS number
179593652
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007370152Ovation iX Iliac Stent GraftTV-IL141280-JTV-IL141280-J2023-03-03
00850007370169Ovation iX Iliac Stent GraftTV-IL1412100-JTV-IL1412100-J2023-03-03
00850007370176Ovation iX Iliac Stent GraftTV-IL1412120-JTV-IL1412120-J2023-03-03
00850007370183Ovation iX Iliac Stent GraftTV-IL1412140-JTV-IL1412140-J2023-03-03
00850007370213Ovation iX Iliac Stent GraftTV-IL1414120-JTV-IL1414120-J2023-03-03
00850007370411Ovation iX Iliac Stent GraftTV-IL1412160-JTV-IL1412160-J2023-03-03
00850007370428Ovation iX Iliac Stent GraftTV-IL1414100-JTV-IL1414100-J2023-03-03
00850007370091Ovation iX Iliac Stent GraftTV-IL1428140-JTV-IL1428140-J2023-03-02
00850007370107Ovation iX Iliac Stent GraftTV-IL141480-JTV-IL141480-J2023-03-02
00850007370114Ovation iX Iliac Stent GraftTV-IL1410160-JTV-IL1410160-J2023-03-02
00850007370190Ovation iX Iliac Stent GraftTV-IL1428120-JTV-IL1428120-J2023-03-02
00850007370206Ovation iX Iliac Stent GraftTV-IL1428100-JTV-IL1428100-J2023-03-02
00850007370220Ovation iX Iliac Stent GraftTV-IL1414140-JTV-IL1414140-J2023-03-02
00850007370237Ovation iX Iliac Stent GraftTV-IL141680-JTV-IL141680-J2023-03-02
00850007370244Ovation iX Iliac Stent GraftTV-IL1416100-JTV-IL1416100-J2023-03-02
00850007370251Ovation iX Iliac Stent GraftTV-IL1416120-JTV-IL1416120-J2023-03-02
00850007370268Ovation iX Iliac Stent GraftTV-IL1416140-JTV-IL1416140-J2023-03-02
00850007370275Ovation iX Iliac Stent GraftTV-IL141880-JTV-IL141880-J2023-03-02
00850007370282Ovation iX Iliac Stent GraftTV-IL1418100-JTV-IL1418100-J2023-03-02
00850007370299Ovation iX Iliac Stent GraftTV-IL1418120-JTV-IL1418120-J2023-03-02

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Primary DI, Brand, Company table
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