LOTUS Edge™ Valve System

Primary DI: 08714729960904
Brand: LOTUS Edge™ Valve System
Company: BOSTON SCIENTIFIC CORPORATION
Model: H749LVSUS230
Catalog number: H749LVSUS230
Device description: Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
Published: 2019-05-02
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: MR Conditional
Rx: true
OTC: false
Sterile: true
Single use: true

Related Records

Product Codes

Code	Name
NPT	Aortic valve, prosthesis, percutaneously delivered

Product Code Classifications

Code	Device	Specialty	Class
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown	3

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
08714729960904	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
08714729960904	08714729960904	8714729960904

GMDN Terms

Term	Definition
Aortic transcatheter heart valve bioprosthesis, stent-like framework	A sterile implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.

Term

Definition

Aortic transcatheter heart valve bioprosthesis, stent-like framework

A sterile implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.

Device Sizes

Type	Value	Unit
Device Size Text, specify	0

Sterilization Methods

Method

Regulatory Flags

DUNS number: 021717889
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

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08714729181132	Percuflex™ Biliary	M00533810		2015-09-24
08714729181149	Percuflex™ Biliary	M00533820		2015-09-24
08714729181156	Percuflex™ Biliary	M00533830		2015-09-24
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