AccessGUDID - DEVICE: LOTUS Edge™ Valve System (08714729960911)

GUDID

Device Identifier (DI) Information

Brand Name: LOTUS Edge™ Valve System
Version or Model: H749LVSUS250
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: H749LVSUS250
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729960911
Issuing Agency: GS1
Commercial Distribution End Date: November 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Transcatheter Aortic Valve Prosthesis Premounted on Delivery System

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60245	Aortic transcatheter heart valve bioprosthesis, stent-like framework	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/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) or transapical access 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPT	Aortic valve, prosthesis, percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 25 mm Diameter

Device Record Status

Public Device Record Key: 69baa1e4-ce18-452f-a765-566ad6901096
Public Version Date: July 04, 2022
Public Version Number: 4
DI Record Publish Date: May 02, 2019