Duns Number:021717889
Device Description: Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
Catalog Number
H749LVSUS230
Brand Name
LOTUS Edge™ Valve System
Version/Model Number
H749LVSUS230
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 17, 2020
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NPT
Product Code Name
Aortic valve, prosthesis, percutaneously delivered
Public Device Record Key
cad68122-50df-436f-a533-54b1a3a74944
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
May 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |