Amplatzer™ 9-VSDMPIHDE-022

GUDID 05415067028136

Post Infarct Muscular VSD Occluder

AGA MEDICAL CORPORATION

Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder

Primary Device ID	05415067028136
NIH Device Record Key	3140c8c7-1e28-427d-8be2-e7fe4a71b02e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Amplatzer™
Version Model Number	Post Infarct Muscular VSD Occluder
Catalog Number	9-VSDMPIHDE-022
Company DUNS	966215829
Company Name	AGA MEDICAL CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com
Phone	+1(855)478-5833
Email	customerservice@sjm.com

Device Dimensions

Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter
Width	10 Millimeter
Height	22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067028136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

H070005

FDA Product Code

MLV	Transcatheter Septal Occluder

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-12-12
Device Publish Date	2017-02-22

On-Brand Devices [Amplatzer™]

00811806012384	Vascular Plug 4
00811806012377	Vascular Plug 4
00811806012360	Vascular Plug 4
00811806012353	Vascular Plug 4
00811806012346	Vascular Plug 4
00811806012087	Delivery Sheath
00811806011851	VSD Muscular Occluder
00811806011844	VSD Muscular Occluder
00811806011837	VSD Muscular Occluder
00811806011820	VSD Muscular Occluder
00811806011813	VSD Muscular Occluder
00811806011806	VSD Muscular Occluder
00811806011790	VSD Muscular Occluder
00811806011783	VSD Muscular Occluder
00811806011530	Sizing Balloon II
00811806011523	Sizing Balloon II
00811806011516	Sizing Balloon II
00811806011264	Duct Occluder II
00811806011240	Duct Occluder II
00811806011233	Duct Occluder II
00811806011219	Duct Occluder II
00811806011202	Duct Occluder II
00811806011189	Duct Occluder II
00811806011172	Duct Occluder II
00811806011141	Duct Occluder
00811806011127	Duct Occluder
00811806011110	Duct Occluder
00811806011103	Duct Occluder
00811806010748	Guidewire
00811806010731	Guidewire
00811806010724	Guidewire
00811806010717	Guidewire
00811806010649	Exchange System
00811806010632	Exchange System
00811806010625	Exchange System
00811806010335	Sizing Plate
00811806010311	MF Septal Occluder Cribriform
00811806010304	MF Septal Occluder Cribriform
00811806010298	MF Septal Occluder Cribriform
00811806010281	MF Septal Occluder Cribriform
00811806010267	Septal Occluder
00811806010250	Septal Occluder
00811806010243	Septal Occluder
00811806010236	Septal Occluder
00811806010229	Septal Occluder
00811806010212	Septal Occluder
00811806010205	Septal Occluder
00811806010199	Septal Occluder
00811806010182	Septal Occluder
00811806010175	Septal Occluder

Trademark Results [Amplatzer]

Mark Image Registration \| Serial	Company Trademark Application Date
AMPLATZER 75263094 2144604 Live/Registered	ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. 1997-03-24