Duns Number:106295384
Device Description: Cardiac Resynchronization Therapy Defibrillator
Catalog Number
-
Brand Name
MOMENTUM™ CRT-D
Version/Model Number
G126
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012,P010012
Product Code
NIK
Product Code Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Public Device Record Key
8cd47fa8-3e5b-4f2f-8b25-1474251689e9
Public Version Date
February 28, 2022
Public Version Number
8
DI Record Publish Date
September 27, 2017
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 |