IntellaNav MiFi™ Open-Irrigated

GUDID 08714729938361

Ablation Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter

Primary Device ID	08714729938361
NIH Device Record Key	d02590d2-5a30-4787-b426-d9350576606c
Commercial Distribution Status	In Commercial Distribution
Brand Name	IntellaNav MiFi™ Open-Irrigated
Version Model Number	M004PMR96200
Company DUNS	021717889
Company Name	BOSTON SCIENTIFIC CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729938361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P150005

FDA Product Code

OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2020-04-28
Device Publish Date	2017-09-11

On-Brand Devices [IntellaNav MiFi™ Open-Irrigated]

08714729938385	Ablation Catheter
08714729938378	Ablation Catheter
08714729938361	Ablation Catheter

Trademark Results [IntellaNav MiFi]

Mark Image Registration \| Serial	Company Trademark Application Date
INTELLANAV MIFI 86027367 5064562 Live/Registered	Boston Scientific Scimed, Inc. 2013-08-02