Duns Number:800214827
Device Description: A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpa A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged).
Catalog Number
8002A-9999
Brand Name
Tapsystem
Version/Model Number
2A re-man'd, unpackaged
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
-
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
P840002,P840002
Product Code
LPA
Product Code Name
System, Esophageal Pacing
Public Device Record Key
865465ea-4f70-4f9f-9cd3-3f880ac36d19
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
July 22, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 17 |