AMDS Hybrid Prosthesis ("AMDS")

Basic Information

• Brand Name: AMDS Hybrid Prosthesis ("AMDS")
• Primary DI: 00877234001215
• Version / Model: K039422
• Catalog Number: AMDS55
• Company Name: Artivion, Inc.
• Labeler DUNS: 119253177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-05
• Public Version: 1
• Public Version Date: 2025-02-13
• Public Version Status: New
• Public Device Record Key: d7cf0049-9917-445e-99f2-487d86ec429a

Device Description

55mm Straight Stent (32mm collar)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
43521	Bare-metal aortic stent	A non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00877234001215	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
H230007	000

Device Sizes

Type	Value	Unit	Text
Catheter Length	565	Millimeter
Device Size Text, specify			Aortic Stent Proximal Diameter: 36-45mm
Device Size Text, specify			Aortic Stent Distal Diameter: 36-45mm
Device Size Text, specify			Aortic Stent Minimum Length:187mm
Device Size Text, specify			Aortic Stent Maximum Length:215mm
Device Size Text, specify			Stent Collar Diameter: 32mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 25 Degrees Celsius